BioDelivery Sciences International, Inc. (NASDAQ: BDSI), a rapidly
growing commercial-stage specialty pharmaceutical company dedicated
to patients living with chronic pain, today announced that a
leading national managed care organization has moved BELBUCA into
preferred status across all its commercial formularies from its
previous position of not-covered effective February 1, 2019. In
addition, patients will no longer require a prior authorization to
receive their BELBUCA script. This significant improvement in
access for more than 7 million covered lives brings the total of
Americans with preferred access for BELBUCA to more than 115
million.
“We are excited to see another major national insurance entity
recognize the clinical value BELBUCA can bring to patients
suffering from chronic pain,” said Herm Cukier, CEO of BDSI.
“Ensuring appropriate access for BELBUCA remains one of our
Company’s top priorities, and the inclusion in this new insurance
plan further demonstrates our commitment to provide patients
unrestricted access to this important therapy for the management of
chronic pain.”
BELBUCA is approved in the U.S. for the management of pain
severe enough to require daily, around-the-clock, long-term opioid
treatment for which alternative treatment options are inadequate.
BELBUCA is the first and only Schedule III long-acting opioid
that uses BDSI’s novel BioErodible MucoAdhesive (BEMA®)
technology.
ABOUT BIODELIVERY SCIENCES INTERNATIONAL,
INC.
BioDelivery Sciences International, Inc. (NASDAQ: BDSI) is
a rapidly growing commercial-stage specialty pharmaceutical company
dedicated to patients living with chronic pain. 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
chronic pain, breakthrough cancer pain, and opioid dependence. For
more information, please visit us at www.bdsi.com or follow us
on Facebook.com/BioDeliverySI or Twitter BDSI @BioDeliverySI.
IMPORTANT SAFETY INFORMATION ABOUT BELBUCA®
BELBUCA® (buprenorphine buccal film), CIII 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.
WARNING: ADDICTION, ABUSE, AND MISUSE; RISK
EVALUATION AND MITIGATION STRATEGY (REMS); LIFE-THREATENING
RESPIRATORY DEPRESSION; ACCIDENTAL EXPOSURE; NEONATAL OPIOID
WITHDRAWAL SYNDROME; and RISKS FROM CONCOMITANT USE WITH
BENZODIAZEPINES AND OTHER CNS
DEPRESSANTSAddiction, Abuse, and
MisuseBELBUCA® 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 for these
behaviors and conditions. Risk Evaluation and
Mitigation Strategy (REMS)To ensure that the
benefits of opioid analgesics outweigh the risks of addiction,
abuse, and misuse, the FDA has required a REMS for these products.
Under the requirements of the REMS, drug companies with approved
opioid analgesic products must make REMS-compliant education
programs available to healthcare providers. Healthcare providers
are strongly encouraged to
- complete a REMS-compliant education
program,
- counsel patients and/or their caregivers, with every
prescription, on safe use, serious risks, storage, and disposal of
these products,
- emphasize to patients and their caregivers the
importance of reading the Medication Guide every time it is
provided by their pharmacist, and
- consider other tools to improve patient, household, and
community safety.
Life-Threatening Respiratory
DepressionSerious, 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.
Accidental ExposureAccidental exposure to
even one dose of BELBUCA®, especially by children, can result in a
fatal overdose of buprenorphine.
Neonatal Opioid Withdrawal
SyndromeProlonged 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
DepressantsConcomitant 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. |
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; and hypersensitivity (e.g., anaphylaxis) to
buprenorphine.
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.
Potential serious adverse events caused by opioids include
addiction, abuse, and misuse; life-threatening respiratory
depression; neonatal opioid withdrawal syndrome; risks due to
interactions with benzodiazepines or other central nervous system
depressants; risk of life-threatening respiratory depression in
patients with chronic pulmonary disease or in elderly, cachectic,
or debilitated patients; adrenal insufficiency; QTc prolongation;
severe hypotension; risks of use in patients with increased
intracranial pressure, brain tumors, head injury, or impaired
consciousness; hepatotoxicity; risk of overdose in patients with
moderate or severe hepatic impairment; anaphylactic/allergic
reactions; risk of use in patients with gastrointestinal
conditions; increased risk of seizures in patients with seizure
disorders; risks of use in cancer patients with oral mucositis;
risks of driving and operating machinery.
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.
For full Prescribing Information, including Boxed
Warning, visit www.belbuca.com.
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.
CAUTIONARY NOTE ON FORWARD-LOOKING
STATEMENTS
This press release, the presentation described herein, and any
statements of employees, representatives, and partners
of BioDelivery Sciences International, Inc. ("BDSI")
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 BDSI'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 BDSI's management and are subject to
significant risks and uncertainties, including those detailed in
the BDSI's filings with the Securities and Exchange
Commission.
Actual results (including, without limitation, the anticipated
benefits to the Company related to the preferred access to
additional commercial lives 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 BDSI's
control). BDSI 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.
© 2019 BioDelivery Sciences International, Inc. All rights
reserved.
Contacts Mary Coleman Vice President, Investor
Relations and Corporate Communications BioDelivery Sciences
International, Inc. 919-582-9050mcoleman@bdsi.com
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