RALEIGH, N.C., Nov. 27, 2017 /PRNewswire/ -- BioDelivery
Sciences International, Inc. (NASDAQ: BDSI) announced that the Ohio
Bureau of Workers Compensation (BWC) has approved a change to
its formulary resulting in
favorable positioning for both BDSI's products BELBUCA®
(buprenorphine) buccal film (CIII) and BUNAVAIL® (buprenorphine and
naloxone) buccal film (CIII). BELBUCA will be added to
the formulary as a Tier 1 long-acting opioid without
restrictions. BUNAVAIL will be added to the formulary and
covered in claims with an allowed condition for opioid use
disorder, while Suboxone film, Suboxone tablet and generic
equivalents, and Subutex tablet and its generic equivalents will be
removed from the formulary.
Ohio leads the nation in
opioid-related overdose deaths with 4,050 drug overdose deaths
reported in 2016, a 33% increase from 2015 according to the Ohio
Department of Health. The addition of BELBUCA and BUNAVAIL to
the formulary followed discussion around steps to combat the
serious opioid epidemic in the state.
"Chronic pain and addiction are serious problems in the work
force and have substantial cost implications. I am pleased to
see that BWC has an appreciation for the attributes of
buprenorphine, and BELBUCA in particular, in treating chronic pain,
including its efficacy and safety profile as well as its Schedule
III designation, particularly given the situation that states
like Ohio face in trying to
aggressively address the opioid crisis," said Dr. Tim Sable, Center for Pain Medicine, Western
Reserve Hospital in Ohio, who
presented to the BWC formulary committee. "Furthermore, BWC
took steps as well to address problems around diversion of certain
buprenorphine/naloxone products for treating addiction by adding
BUNAVAIL in place of other buprenorphine and buprenorphine/naloxone
products, including Suboxone sublingual film, on their
formulary."
"We are very pleased that the BWC formulary committee recognized
the need for access to Schedule III treatments for chronic pain,
such as BELBUCA, with less abuse and addiction potential compared
to Schedule II options," said Dr. Mark A.
Sirgo, Vice Chairman, President and CEO of BDSI. "The
action taken with BUNAVAIL also recognizes its attributes in this
environment. We are encouraged that these actions may be taken by
others in the future."
The Ohio Bureau of Workers Compensation is the largest
state-funded insurance system in the U.S. and one of the top 10
largest underwriters of workers' compensation insurance in the
nation, insuring 244,000 Ohio
employers and providing insurance coverage to approximately 60% of
Ohio's workforce. The
changes to the formulary will go into effect April 1, 2018.
ABOUT BELBUCA® (BUPRENORPHINE)
BUCCAL FILM (CIII)
INDICATION
BELBUCA® (buprenorphine) buccal
film is indicated for the management of pain severe enough to
require daily, around-the-clock, long-term opioid treatment and for
which alternative treatment options are inadequate.
Limitations of Use
Because of the risks of addiction, abuse, and misuse with opioids,
even at recommended doses, and because of the greater risks of
overdose and death with long-acting opioid formulations, reserve
BELBUCA® for use in patients for whom
alternative treatment options (e.g., non-opioid analgesics or
immediate-release opioids) are ineffective, not tolerated, or would
be otherwise inadequate to provide sufficient management of
pain.
BELBUCA® is not indicated as an
as-needed (prn) analgesic.
IMPORTANT SAFETY INFORMATION about
BELBUCA®
WARNING: ADDICTION, ABUSE, AND MISUSE;
LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL
EXPOSURE; AND NEONATAL OPIOID WITHDRAWAL SYNDROME AND
RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES AND OTHER CNS
DEPRESSANTS
Addiction, Abuse, and
Misuse
BELBUCA® exposes
patients and other users to the risks of opioid addiction, abuse,
and misuse, which can lead to overdose and death. Assess patient's
risk prior to prescribing
BELBUCA®, and monitor
patients regularly these behaviors and conditions.
Life-Threatening Respiratory Depression
Serious,
life-threatening, or fatal respiratory depression may occur with
use of BELBUCA®. Monitor for
respiratory depression, especially during initiation of
BELBUCA® or following a
dose increase. Misuse or abuse of
BELBUCA® by chewing,
swallowing, snorting, or injecting buprenorphine extracted from the
buccal film will result in the uncontrolled delivery of
buprenorphine and pose a significant risk of overdose and
death.
Accidental Exposure
Accidental exposure to even one
dose of BELBUCA®, especially
by children, can result in a fatal overdose of
buprenorphine.
Neonatal Opioid Withdrawal Syndrome
Prolonged use
of BELBUCA® during
pregnancy can result in neonatal opioid withdrawal syndrome, which
may be life-threatening if not recognized and treated, and requires
management according to protocols developed by neonatology experts.
If opioid use is required for a prolonged period in a pregnant
woman, advise the patient of the risk of neonatal opioid withdrawal
syndrome and ensure that appropriate treatment will be
available.
Risks from Concomitant Use With Benzodiazepines Or Other CNS
Depressants
Concomitant use of opioids with
benzodiazepines or other central nervous system (CNS) depressants,
including alcohol, may result in profound sedation, respiratory
depression, coma, and death. Reserve concomitant prescribing
for use in patients for whom alternative treatment options are
inadequate; limit dosages and durations to the minimum required;
and follow patients for signs and symptoms of respiratory
depression and sedation.
CONTRAINDICATIONS
BELBUCA® is contraindicated in
patients with significant respiratory depression, acute or severe
bronchial asthma in an unmonitored setting or in the absence of
resuscitative equipment, known or suspected gastrointestinal
obstruction, including paralytic ileus, hypersensitivity (e.g.,
anaphylaxis) to buprenorphine.
WARNINGS AND PRECAUTIONS
Addiction, Abuse, and Misuse
BELBUCA® contains buprenorphine, a
Schedule III controlled substance. As an opioid,
BELBUCA® exposes users to the risks of
addiction, abuse, and misuse. Although the risk of addiction
in any individual is unknown, it can occur in patients
appropriately prescribed BELBUCA® and
in those who obtain the drug illicitly. Addiction can occur at
recommended doses and if the drug is misused or abused.
Assess each patient's risk for opioid addiction, abuse, or
misuse prior to prescribing BELBUCA®, and
monitor all patients receiving
BELBUCA® for the development of these
behaviors and conditions. Risks are increased in patients with a
personal or family history of substance abuse (including drug or
alcohol abuse or addiction) or mental illness (e.g., major
depression). The potential for these risks should not, however,
prevent the proper management of pain in any given patient.
Patients at increased risk may be prescribed opioids such as
BELBUCA®, but use in such patients
necessitates intensive counseling about the risks and proper use of
BELBUCA®, along with intensive monitoring
for signs of addiction, abuse, or misuse.
Abuse or misuse of BELBUCA® by
swallowing may cause choking, overdose, and death.
Opioids are sought by drug abusers and people with addiction
disorders and are subject to criminal diversion. Consider these
risks when prescribing or dispensing
BELBUCA®. Strategies to reduce the risk
include prescribing the drug in the smallest appropriate quantity
and advising the patient on the proper disposal of unused drug.
Life-Threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory depression has been
reported with the use of opioids, even when used as recommended.
Respiratory depression, if not immediately recognized and treated,
may lead to respiratory arrest and death.
While serious, life-threatening or fatal respiratory depression
can occur at any time during the use of
BELBUCA®, the risk is greatest during
initiation of therapy or following a dosage increase. Monitor
patients closely for respiratory depression when initiating therapy
with BELBUCA® and following dosage
increases.
To reduce the risk of respiratory depression, proper dosing and
titration of BELBUCA® are essential.
Overestimating the dose of
BELBUCA® when converting patients from
another opioid product may result in fatal overdose with the first
dose.
Accidental exposure to BELBUCA®,
especially in children, can result in respiratory depression and
death due to an overdose of buprenorphine.
Neonatal Opioid Withdrawal Syndrome
Prolonged use of BELBUCA® during
pregnancy can result in withdrawal in the neonate. Neonatal opioid
withdrawal syndrome, unlike opioid withdrawal syndrome in adults,
may be life-threatening if not recognized and treated and requires
management according to protocols developed by neonatology experts.
Observe newborns for signs of neonatal opioid withdrawal syndrome
and manage accordingly. Advise pregnant women using opioids
for a prolonged period of the risk of neonatal opioid withdrawal
syndrome and ensure that appropriate treatment will be
available.
Risks due to Interactions with Benzodiazepines or Other Central
Nervous System Depressants
Profound sedation, respiratory depression, coma, and death may
result from the concomitant use of
BELBUCA® with benzodiazepines or other
CNS depressants (e.g., non-benzodiazepine sedatives/hypnotics,
anxiolytics, tranquilizers, muscle relaxants, general anesthetics,
antipsychotics, other opioids, alcohol). Because of these risks,
reserve concomitant prescribing of these drugs for use in patients
for whom alternative treatment options are inadequate.
If the decision is made to prescribe a benzodiazepine or other
CNS depressant concomitantly with an opioid analgesic, prescribe
the lowest effective dosages and minimum durations of concomitant
use. Follow patients closely for signs and symptoms of
respiratory depression and sedation.
Risk of Life-Threatening Respiratory Depression in Patients with
Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated
Patients
The use of BELBUCA® in patients with
acute or severe bronchial asthma in an unmonitored setting or in
the absence of resuscitative equipment is contraindicated.
Patients with Chronic Pulmonary Disease:
BELBUCA®-treated patients with significant
chronic obstructive pulmonary disease or cor pulmonale, and those
with substantially decreased respiratory reserve, hypoxia,
hypercapnia, or pre-existing respiratory depression are at
increased risk of decreased respiratory drive, including apnea,
even at recommended dosages of
BELBUCA®.
Life-threatening respiratory depression is more likely to occur
in in elderly, cachectic, or debilitated patients as they may have
altered pharmacokinetics or altered clearance compared with
younger, healthier patients.
Monitor such patients closely, particularly when initiating and
titrating BELBUCA® and when
BELBUCA® is given concomitantly with
other drugs that depress respiration.
Adrenal Insufficiency
Cases of adrenal insufficiency have been reported with opioid use,
more often following greater than one month of use. Presentation of
adrenal insufficiency may include non-specific symptoms and signs
including nausea, vomiting, anorexia, fatigue, weakness, dizziness,
and low blood pressure. If adrenal insufficiency is suspected,
confirm the diagnosis with diagnostic testing as soon as possible.
If adrenal insufficiency is diagnosed, treat with physiologic
replacement doses of corticosteroids. Wean the patient off of the
opioid to allow adrenal function to recover and continue
corticosteroid treatment until adrenal function recovers. Other
opioids may be tried as some cases reported use of a different
opioid without recurrence of adrenal insufficiency. The information
available does not identify any particular opioids as being more
likely to be associated with adrenal insufficiency.
QTc Prolongation
BELBUCA® has been observed to prolong
the QTc interval in some subjects participating in clinical trials.
Consider these observations in clinical decisions when prescribing
BELBUCA®™ to
patients with hypokalemia, hypomagnesemia, or clinically unstable
cardiac disease, including unstable atrial fibrillation,
symptomatic bradycardia, unstable congestive heart failure, or
active myocardial ischemia. Periodic electrocardiographic (ECG)
monitoring is recommended in these patients. Avoid the use of
BELBUCA® in patients with a history of
Long QT Syndrome (or an immediate family member with this
condition) or those taking Class IA antiarrhythmic medications
(e.g., quinidine, procainamide, disopyramide) or Class III
antiarrhythmic medications (e.g., sotalol, amiodarone, dofetilide),
or other medications that prolong the QT interval.
Severe Hypotension
BELBUCA® may cause severe hypotension,
including orthostatic hypotension and syncope, in ambulatory
patients. There is an increased risk in patients whose ability to
maintain blood pressure has already been compromised by a reduced
blood volume or concurrent administration of certain CNS depressant
drugs (e.g., phenothiazines or general anesthetics). Monitor these
patients for signs of hypotension after initiating or titrating the
dosage of BELBUCA®. In patients with circulatory shock
BELBUCA® may cause vasodilation that
can further reduce cardiac output and blood pressure. Avoid the use
of BELBUCA® in patients with
circulatory shock.
Risks of Use in Patients with Increased Intracranial Pressure,
Brain Tumors, Head Injury, or Impaired Consciousness
In patients who may be susceptible to the intracranial effects
of CO2 retention (e.g., those with evidence of
increased intracranial pressure or brain tumors),
BELBUCA® may reduce respiratory drive,
and the resultant CO2 retention can further
increase intracranial pressure. Monitor such patients for signs of
sedation and respiratory depression, particularly when initiating
therapy with BELBUCA®.
Opioids may also obscure the clinical course in a patient with a
head injury. Avoid the use of
BELBUCA® in patients with impaired
consciousness or coma.
Hepatotoxicity
Cases of cytolytic hepatitis and hepatitis with jaundice have been
observed in individuals receiving sublingual formulations of
buprenorphine for the treatment of opioid dependence, both in
clinical trials and in post-marketing adverse events reports. For
patients at increased risk of hepatotoxicity (e.g., patients with a
history of excessive alcohol intake, intravenous drug abuse or
liver disease), obtain baseline liver enzyme levels and monitor
periodically during treatment with
BELBUCA®.
Risk of Overdose in Patients With Moderate or Severe Hepatic
Impairment
In a pharmacokinetic study of subjects dosed with buprenorphine
sublingual tablets, buprenorphine plasma levels were found to be
higher and the half-life was found to be longer in subjects with
moderate and severe hepatic impairment but not in subjects with
mild hepatic impairment. For patients with severe hepatic
impairment, a dose adjustment is recommended, and patients with
moderate or severe hepatic impairment should be monitored for signs
and symptoms of toxicity or overdose caused by increased levels of
buprenorphine.
Anaphylactic/Allergic Reactions
Cases of acute and chronic hypersensitivity to buprenorphine have
been reported both in clinical trials and in post-marketing
experience. The most common signs and symptoms include rashes,
hives, and pruritus. Cases of bronchospasm, angioneurotic edema,
and anaphylactic shock have been reported.
Risk of Use in Patients with Gastrointestinal Conditions
BELBUCA® is contraindicated in patients
with known or suspected gastrointestinal obstruction, including
paralytic ileus.
BELBUCA® may cause spasm of the
sphincter of Oddi. Opioids may cause increases in the serum
amylase. Monitor patients with biliary tract disease, including
acute pancreatitis, for worsening symptoms.
Increased Risk of Seizures in Patients with Seizure
Disorders
The buprenorphine in BELBUCA® may increase
the frequency of seizures in patients with seizure disorders and
may increase the risk of seizures occurring in other clinical
settings associated with seizures. Monitor patients with a history
of seizure disorders for worsened seizure control during
BELBUCA® therapy.
Risks of Use in Cancer Patients with Oral Mucositis
Cancer patients with oral mucositis may absorb buprenorphine more
rapidly than intended and are likely to experience transiently
higher plasma levels of the opioid. A dose reduction is recommended
in these patients. Monitor carefully for signs and symptoms of
toxicity or overdose caused by increased levels of
buprenorphine.
Risks of Driving and Operating Machinery
BELBUCA® may impair the mental and
physical abilities needed to perform potentially hazardous
activities such as driving a car or operating machinery. Warn
patients not to drive or operate dangerous machinery unless they
are tolerant to side effects of
BELBUCA® and know how they will react
to the medication.
ADVERSE REACTIONS
The most common adverse reactions (≥5%) reported by patients
treated with BELBUCA® in the clinical
trials were nausea, constipation, headache, vomiting, fatigue,
dizziness, somnolence, diarrhea, dry mouth, and upper respiratory
tract infection.
Please see full Prescribing Information,
including Boxed Warning and Medication Guide, for
BELBUCA®.
ABOUT BUNAVAIL® (BUPRENORPHINE AND
NALOXONE) BUCCAL FILM (CIII)
INDICATION
BUNAVAIL® (buprenorphine and naloxone)
Buccal Film (CIII) is indicated for the treatment of opioid
dependence and should be used as part of a complete treatment plan
to include counseling and psychosocial support.
Prescription use of this product is limited under the Drug
Addiction Treatment Act (DATA).
IMPORTANT SAFETY INFORMATION
Keep BUNAVAIL
(buprenorphine and naloxone) Buccal Film (CIII) out of the sight
and reach of children. Ingestion of BUNAVAIL by a child may
cause severe breathing problems and death. If a child takes
BUNAVAIL, get emergency help right away.
Do not take BUNAVAIL if you are allergic to buprenorphine or
naloxone, as serious negative effects including anaphylactic shock,
have been reported.
Do not take BUNAVAIL before the effects of other opioids (e.g.,
heroin, methadone, oxycodone, morphine) have lessened as you may
experience withdrawal symptoms.
BUNAVAIL is not appropriate as an analgesic. There have
been reported deaths of opioid naïve individuals who received a
buprenorphine dose smaller than the lowest available BUNAVAIL
strength.
Do not drive, operate heavy machinery, or perform any other
dangerous activities until you know how BUNAVAIL affects you.
BUNAVAIL contains buprenorphine, an opioid that can cause
physical dependence. Your doctor can tell you more about the
difference between physical dependence and drug addiction. Do not
stop taking BUNAVAIL without talking to your doctor. You could
become sick with uncomfortable withdrawal symptoms because your
body has become used to this medicine.
Do not switch from BUNAVAIL to other medicines that contain
buprenorphine without talking with your doctor. The amount of
buprenorphine in a dose of BUNAVAIL is not the same as the amount
of buprenorphine in other medicines. Your doctor will
prescribe a dose of BUNAVAIL that may be different than other
buprenorphine-containing medicines you may have been taking.
BUNAVAIL can cause serious life‐threatening breathing problems,
overdose and death, particularly when taken by the intravenous (IV)
route in combination with benzodiazepines, sedatives, tranquilizers
or alcohol. You should not drink alcohol while taking
BUNAVAIL, as this can lead to loss of consciousness or even
death.
Consider dose reduction of CNS depressants, BUNAVAIL buccal
film, or both in situations of concomitant prescription.
Like other opioids (e.g., heroin, methadone, oxycodone,
morphine), BUNAVAIL may produce orthostatic hypotension ('dizzy
spells') in ambulatory individuals.
Common side effects of BUNAVAIL include headache, drug
withdrawal syndrome, lethargy (lack of energy), sweating,
constipation, decrease in sleep (insomnia), fatigue and
sleepiness.
Cases of adrenal insufficiency, a potentially-life threatening
condition, have been reported with opioid use, more often following
greater than one month of treatment.
Monitor liver function tests prior to initiation and during
treatment and evaluate suspected hepatic events.
Because BUNAVAIL contains naloxone, injecting BUNAVAIL may cause
serious withdrawal symptoms such as pain, cramps, vomiting,
diarrhea, anxiety, sleep problems, and cravings.
BUNAVAIL can be abused in a manner similar to other opioids,
legal or illicit. Keep BUNAVAIL in a safe place. Do not give
your BUNAVAIL to other people, it can cause them harm or even
death. Selling or giving away this medicine is against the law.
BUNAVAIL is not recommended in patients with severe hepatic
impairment. BUNAVAIL may be used with caution for maintenance
treatment in patients with moderate hepatic impairment.
Before taking BUNAVAIL, tell your doctor if you are pregnant or
plan to become pregnant. If you become pregnant while taking
BUNAVAIL, tell your doctor immediately as there may be significant
risks to you and your baby; your baby may have symptoms of
withdrawal at birth.
Neonatal opioid withdrawal syndrome (NOWS) is an expected and
treatable outcome of prolonged use of opioids during pregnancy,
whether that use is medically-authorized or illicit.
Before taking BUNAVAIL, talk to your doctor if you are
breast‐feeding or plan to breast‐feed your baby. BUNAVAIL can pass
into your breast milk and may harm your baby. Monitor your
baby for increased sleepiness and breathing problems. Your
doctor should tell you about the best way to feed your baby if you
are taking BUNAVAIL.
This is not a complete list of potential adverse events
associated with BUNAVAIL Buccal Film. Please see full Prescribing
Information for a complete list.
To report negative side effects associated with taking BUNAVAIL
Buccal Film, please call 1‑800-469-0261. You are encouraged
to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1‐800‐FDA‐1088.
For more information, please see full Prescribing
Information and Medication Guide for BUNAVAIL® Buccal Film
(CIII).
About BioDelivery Sciences International
BioDelivery Sciences International, Inc. (NASDAQ: BDSI) is a
specialty pharmaceutical company with a focus in the areas of pain
management and addiction medicine. BDSI is utilizing its
novel and proprietary BioErodible MucoAdhesive
(BEMA®) technology and other drug delivery
technologies to develop and commercialize, either on its own or in
partnership with third parties, new applications of proven
therapies aimed at addressing important unmet medical needs.
BDSI's marketed products and those in development address
serious and debilitating conditions such as breakthrough cancer
pain, chronic pain and opioid dependence. BDSI's headquarters
is in Raleigh, North Carolina.
For more information, please visit or follow us:
Internet:
www.bdsi.com
Facebook: Facebook.com/BioDeliverySI
Twitter:
@BioDeliverySI
BUNAVAIL® (buprenorphine and
naloxone) buccal film (CIII) and BELBUCA®
(buprenorphine) buccal film (CIII) are marketed in the U.S. by
BioDelivery Sciences. ONSOLIS® (fentanyl
buccal soluble film) (CII) is licensed in the U.S. to Collegium
Pharmaceutical pursuant to the U.S. licensing and development
agreement between BDSI and Collegium. For full prescribing
information and important safety information on BDSI products,
including BOXED WARNINGS for ONSOLIS, please visit
www.bdsi.com where the Company promptly posts press
releases, SEC filings and other important information or contact
the Company at (800) 469-0261. For full prescribing and
safety information on BELBUCA, please visit
www.belbuca.com and for full prescribing and safety
information on BUNAVAIL, please visit www.bunavail.com.
Cautionary Note on Forward-Looking Statements
This press release and any statements of employees,
representatives and partners of BioDelivery Sciences International,
Inc. (the "Company") related thereto contain, or may contain, among
other things, certain "forward-looking statements" within the
meaning of the Private Securities Litigation Reform Act of
1995. Such forward-looking statements involve significant
risks and uncertainties. Such statements may include, without
limitation, statements with respect to the Company's plans,
objectives, projections, expectations and intentions and other
statements identified by words such as "projects," "may," "will,"
"could," "would," "should," "believes," "expects," "anticipates,"
"estimates," "intends," "plans," "potential" or similar
expressions. These statements are based upon the current
beliefs and expectations of the Company's management and are
subject to significant risks and uncertainties, including those
detailed in the Company's filings with the Securities and Exchange
Commission. Actual results (including, without limitation,
the marketing and sales results of the Ohio forumulary positioning for BELBUCA
and BUNAVAIL described herein)
may differ significantly from those set forth or implied in the
forward-looking statements. These forward-looking statements
involve certain risks and uncertainties that are subject to change
based on various factors (many of which are beyond the Company's
control). The Company undertakes no obligation to publicly
update any forward-looking statements, whether as a result of new
information, future presentations or otherwise, except as required
by applicable law.
BDSI®, BEMA®,
ONSOLIS®, BUNAVAIL®
and BELBUCA® are registered trademarks of
BioDelivery Sciences International, Inc. The BioDelivery
Sciences, BUNAVAIL and BELBUCA logos are trademarks owned by
BioDelivery Sciences International, Inc. All other trademarks
and tradenames are owned by their respective owners.
© 2017 BioDelivery Sciences International, Inc. All rights
reserved.
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