RALEIGH, N.C., Sept. 12, 2017 /PRNewswire/ -- BioDelivery
Sciences International, Inc. (NASDAQ: BDSI) announced today that
Health Canada has granted market authorization to formally transfer
the Drug Identification Number (DIN) ownership of BELBUCA®
(buprenorphine) buccal film in Canada to BDSI's commercial partner, Purdue
Pharma (Canada). As
previously announced, this approval triggers a milestone payment to
BDSI.
Dr. Mark A. Sirgo, Vice Chairman, President and Chief
Executive Officer of BDSI commented, "We congratulate our partners
at Purdue Pharma (Canada) on this
important milestone, and we look forward to the launch in
Canada."
BELBUCA incorporates BDSI's BioErodible MucoAdhesive (BEMA®)
drug delivery technology and is the first and only long-acting
opioid that uses novel buccal film technology to deliver
buprenorphine for appropriate patients living with chronic pain.
BELBUCA was approved in Canada in
June 2017 for the management of pain
severe enough to require daily, continuous, long-term treatment and
that is opioid-responsive and for which alternative options are
inadequate.
Purdue Pharma (Canada) and BDSI
announced on July 12, 2017 that the
companies had signed an exclusive agreement for the licensing,
distribution, marketing and sale of BELBUCA in Canada.
About BELBUCA® (buprenorphine) buccal film
(CIII)
INDICATION in Canada
BELBUCA® (buprenorphine) buccal film is
indicated in Canada for the
management of pain severe enough to require daily, continuous,
long-term treatment and that is opioid-responsive and for which
alternative options are inadequate.
The following information is included in the US Product
Label:
INDICATION in the United
States
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®.
To report SUSPECTED ADVERSE REACTIONS, contact BioDelivery
Sciences International, Inc. at 1-800-469-0261 or FDA
at 1-800-FDA-1088 or www.fda.gov/safety/medwatch.
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:
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Internet:
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www.bdsi.com
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Facebook:
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Facebook.com/BioDeliverySI
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Twitter:
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@BioDeliverySI
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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 anticipated Canadian launch timeframe for BELBUCA in
Canada and the results of the
Company's commercialization programs for BELBUCA, including in
Canada as 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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