BioDelivery Sciences International, Inc. (NASDAQ: BDSI), a
specialty pharmaceutical company dedicated to patients living with
chronic conditions, today announced that several regional health
care plans improved patient access to BELBUCA® (buprenorphine
buccal film), CIII, during the second quarter of this year.
Several prominent regional U.S. insurance plans representing an
additional six million covered lives enhanced BELBUCA’s coverage to
preferred status or initiated coverage for BELBUCA. These six
million covered lives brings the total number of commercial lives
with access to BELBUCA to more than 165 million, representing more
than 90% of the U.S. commercial insurance market.
“We continue to see strong interest and
acceptance by payers for BELBUCA, and our steadfast progress
further enables us to build upon our current growth momentum,”
stated Scott Plesha, President and Chief Commercial Officer of
BDSI. “Consistent with our stated strategy for 2019, we are
achieving our goal of expanding access to BELBUCA with regional
plans across the country and anticipate continued progress.”
“We are very pleased by the increased
appreciation of the clinical value that BELBUCA can bring to
patients suffering from chronic pain and remain committed to
ensuring these patients have appropriate access to BELBUCA,” stated
Herm Cukier, CEO of BDSI. “The prevalence of chronic
pain in the U.S. is significant, and our efforts to enhance patient
access to BELBUCA fully aligns with the recently published Pain
Management Best Practices Inter-Agency Task Force’s report for
managing chronic pain. The report specifically encouraged payers to
provide coverage and reimbursement for buprenorphine for chronic
pain. As a result, we have experienced a considerable
increase in interest from payers regarding BELBUCA since the Task
Force report was issued.”
BELBUCA® (buprenorphine buccal film), CIII, 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
utilizes BDSI's patented BioErodible MucoAdhesive (BEMA®) drug
delivery technology to deliver buprenorphine, which is a
Schedule III (or C III) medicine. Schedule III drugs,
substances, or chemicals are defined as drugs with a moderate to
low potential for physical and psychological dependence.
Schedule III drugs abuse potential is less than Schedule I and
Schedule II drugs.
For more information on BELBUCA, visit www.belbuca.com.
For more information on the DEA drug schedule classification,
visit https://www.dea.gov/drug-scheduling.
Please see Important Safety Information about BELBUCA
below. For full Prescribing Information, including Boxed
Warning, visit www.belbuca.com.
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 conditions. 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 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 and any statements of
employees, representatives, and partners of 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 may differ materially 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) including those set forth in our
2018 annual report on Form 10-K filed with the US Securities
and Exchange Commission and subsequent filings. 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
BioDelivery Sciences (NASDAQ:BDSI)
Historical Stock Chart
From Mar 2024 to Apr 2024
BioDelivery Sciences (NASDAQ:BDSI)
Historical Stock Chart
From Apr 2023 to Apr 2024