Showing posts sorted by relevance for query Buprenorphine. Sort by date Show all posts
Showing posts sorted by relevance for query Buprenorphine. Sort by date Show all posts

Thursday, September 22, 2016

Expand prescribing of buprenorphine for opioid abuse? Experts weigh pros and cons....

In continuation of my update on Buprenorphine
Buprenorphine is a critical part of treatment for the growing epidemic of opioid abuse--but also carries the potential for misuse and diversion. The debate over whether 'to expand or not to expand' prescribing of buprenorphine for opioid abuse is discussed in an expert review in the Journal of Psychiatric Practice, published by Wolters Kluwer.
Image result for buprenorphine structure




Based on the strong evidence of effectiveness, "We should not limit or impede the use and expansion of buprenorphine therapy," write Drs. Xiaofan Li, Daryl Shorter, and Thomas Kosten, of the Menninger Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine and Michael E. DeBakey Veterans Affairs Medical Center, Houston, Texas. They propose specific strategies to promote buprenorphine use while ensuring quality of care and reducing the risk of diversion and abuse.
Focus on Expanding Buprenorphine Use 'Safely and Effectively'
A "partial agonist" of the μ-opioid receptor in the brain, buprenorphine has similar actions to other opioids, but with less potential for abuse and a more favorable safety profile. Because it reduces demand for opioids, buprenorphine therapy is an effective deterrence strategy to combat opioid abuse. The authors cite studies suggesting that access to buprenorphine therapy can sharply reduce heroin mortality--including reductions of more than 50 percent in France and 37 percent in Baltimore.
Compared to methadone--long the standard for treating opioid and heroin addiction--buprenorphine poses lower risks related to diversion and non-medical use. The most commonly prescribed form of buprenorphine includes the opioid antagonist (blocker) naloxone, decreasing the potential for intravenous abuse.
But there are strict controls on prescribing of buprenorphine, which is classified as a Schedule III controlled substance in the United States. To prescribe buprenorphine in office-based settings, physicians must receive a Drug Enforcement Agency (DEA) waiver, complete special training, and comply with limits on the number of treated patients.
While medical use of buprenorphine has skyrocketed over the past decade, most prescribers are located in urban areas. It is estimated that 53 percent of US counties do not have any physician with a DEA waiver to prescribe buprenorphine.
Measures to make buprenorphine treatment more accessible have been proposed, such as allowing prescribing by qualified advanced nurse practitioners and physician assistants and loosening limits on number of patients treated. But these measures have been controversial, reflecting legitimate concerns about increased potential for diversion and abuse. Data show that, as use of buprenorphine to treat opioid use disorder has increased, so have the rates of misuse and diversion.
Drs. Li, Shorter, and Kosten raise special concern about the recent emergence of intravenous buprenorphine abuse. They write, "This real-world, almost paradoxical, phenomenon demonstrates the complexity inherent in the treatment of addictive disorders--a medication intended to treat substance use disorder that has its own abuse potential, upon gaining popularity and increased availability, will inevitably be explored by drug abusers for reward and reinforcement purposes."
Earlier this year, President Obama announced an initiative to increase access to effective medications for treating opioid addiction--specifically, buprenorphine and naloxone. Drs. Li, Shorter, and Kosten outline strategies to expand effective treatment with buprenorphine while reducing the risks of diversion and abuse, including:
  • Additional support for physicians with high caseloads and other measures to help prescribers comply with guidelines.
  • Continuing medical education targeting improvements in office-based therapy for opioid abuse.
  • Policies and regulations promoting safe practice.
  • Financial incentives coupled with mandatory enforcement of essential components of safe practice.
  • More active pharmacy involvement, including supervised dispensing.
  • Identification of groups at high risk of intravenous buprenorphine abuse.
"The question is not whether or not to expand buprenorphine prescribing," the authors add. "It is how to expand buprenorphine prescribing safely and effectively."
Ref :1. http://journals.lww.com/practicalpsychiatry/pages/articleviewer.aspx?year=2016&issue=05000&article=00004&type=abstract

 http://dx.doi.org/10.1097/PRA.0000000000000154


Friday, December 29, 2017

FDA Approves Sublocade (buprenorphine) Once-Monthly Injection for Opioid Use Disorder

In continuation of my update on Sublocade (buprenorphine)
Skeletal formula of buprenorphine

The U.S. Food and Drug Administration today approved Sublocade, the first once-monthly injectable buprenorphine product for the treatment of moderate-to-severe opioid use disorder (OUD) in adult patients who have initiated treatment with a transmucosal (absorbed through mucus membrane) buprenorphine-containing product. It is indicated for patients that have been on a stable dose of buprenorphine treatment for a minimum of seven days.
Buprenorphine for the treatment of OUD is currently approved to administer as a tablet or film that dissolves in the mouth, or as an implant. Sublocade provides a new treatment option for patients in recovery who may value the benefits of a once-monthly injection compared to other forms of buprenorphine, such as reducing the burden of taking medication daily as prescribed (medical adherence). An independent FDA advisory committee supported the approval of Sublocade at a meeting held last month.
"Given the scale of the opioid crisis, with millions of Americans already affected, the FDA is committed to expanding access to treatments that can help people pursue lives of sobriety. Everyone who seeks treatment for opioid use disorder deserves the opportunity to be offered the treatment best suited to the needs of each individual patient, in combination with counseling and psychosocial support, as part of a comprehensive recovery plan,” said FDA Commissioner Scott Gottlieb, M.D. “As part of our ongoing work in supporting the treatment of those suffering from addiction to opioids, the FDA plans to issue guidance to expedite the development of new addiction treatment options. We’ll continue to pursue efforts to promote more widespread use of existing, safe and effective FDA-approved therapies to treat addiction.”
Improving access to prevention, treatment and recovery services, including the full range of medication-assisted treatments (MAT), is a focus of the FDA’s ongoing work to reduce the scope of the opioid crisis and one part of the U.S. Department of Health and Human Services’ Five-Point Strategy to Combat the Opioid Crisis.
OUD is the diagnostic term used for a chronic neurobiological disease characterized by a problematic pattern of opioid use leading to significant impairment or distress and includes signs and symptoms that reflect compulsive, prolonged self-administration of opioid substances for no legitimate medical purpose or, if another medical condition is present that requires opioid treatment, the opioid is used in doses far greater than the amount needed for treatment of that medical condition.
MAT is a comprehensive approach that combines approved medications (currently, methadone, buprenorphine or naltrexone) with counseling and other behavioral therapies to treat patients with OUD. Regular adherence to MAT with buprenorphine reduces opioid withdrawal symptoms and the desire to use opioids, without causing the cycle of highs and lows associated with opioid misuse or abuse. At proper doses, buprenorphine also decreases the pleasurable effects of other opioids, making continued opioid abuse less attractive. According to the Substance Abuse and Mental Health Services Administration, patients receiving MAT for their OUD cut their risk of death from all causes in half.
Sublocade should be used as part of a complete treatment program that includes counseling and psychosocial support. Sublocade is a drug-device combination product that utilizes buprenorphine and the Atrigel Delivery System in a pre-filled syringe. It is injected by a health care professional (HCP) under the skin (subcutaneously) as a solution, and the delivery system forms a solid deposit, or depot, containing buprenorphine. After initial formation of the depot, buprenorphine is released by the breakdown (biodegradation) of the depot. In clinical trials, Sublocade provided sustained therapeutic plasma levels of buprenorphine over the one-month dosing interval.
The safety and efficacy of Sublocade were evaluated in two clinical studies (one randomized controlled clinical trial and one open-label clinical trial) of 848 adults with a diagnosis of moderate-to-severe OUD who began treatment with buprenorphine/naloxone sublingual film (absorbed under the tongue). Once the dose was determined stable, patients were given Sublocade by injection. A response to MAT was measured by urine drug screening and self-reporting of illicit opioid use during the six-month treatment period. Results indicated that Sublocade-treated patients had more weeks without positive urine tests or self-reports of opioid use, and a higher proportion of patients had no evidence of illicit opioid use throughout the treatment period, compared to the placebo group.
The most common side effects from treatment with Sublocade include constipation, nausea, vomiting, headache, drowsiness, injection site pain, itching (pruritus) at the injection site and abnormal liver function tests. The safety and efficacy of Sublocade have not been established in children or adolescents less than 17 years of age. Clinical studies of Sublocade did not include participants over the age of 65.
The FDA is requiring postmarketing studies to assess which patients would benefit from a higher dosing regimen, to determine whether Sublocade can be safely initiated without a dose stabilization period of sublingual buprenorphine, to assess the feasibility of administering Sublocade at a longer inter-dose interval than once-monthly and to determine a process for transitioning patients with long-term stability on a transmucosal buprenorphine dose to a monthly dose of Sublocade without the use of a higher dose for the first two months of treatment (loading dose).
Sublocade has a boxed warning that provides important safety information, including the risks of intravenous self-administration. If the product were to be administered intravenously rather than subcutaneously, the solid mass could cause occlusion (blockage), tissue damage or embolus (solid material that is carried in the blood and can become lodged in a blood vessel, which can lead to death). Sublocade must be prescribed and dispensed as part of a Risk Evaluation and Mitigation Strategy (REMS) to ensure that the product is not distributed directly to patients. Sublocade will be provided to HCPs through a restricted program, administered only by HCPs in a health care setting, and will require health care settings and pharmacies that dispense Sublocade to complete an enrollment form attesting that they have procedures in place to ensure that Sublocade is dispensed only to HCPs and not directly to patients.

Tuesday, November 22, 2016

First buprenorphine implant for opioid dependence treatment gets FDA approval

The U.S. Food and Drug Administration today approved Probuphine, the first buprenorphine implant for the maintenance treatment of opioid dependence. Probuphine is designed to provide a constant, low-level dose of buprenorphine for six months in patients who are already stable on low-to-moderate doses of other forms of buprenorphine, as part of a complete treatment program.

Until today, buprenorphine for the treatment of opioid dependence was only approved as a pill or a film placed under the tongue or on the inside of a person's cheek until it dissolved. While effective, a pill or film may be lost, forgotten or stolen. However, as an implant, Probuphine provides a new treatment option for people in recovery who may value the unique benefits of a six-month implant compared to other forms of buprenorphine, such as the possibility of improved patient convenience from not needing to take medication on a daily basis. An independent FDA advisory committee supported the approval of Probuphine in a meeting held earlier this year.
SUBUTEX (buprenorphine) Structural Formula Illustration

"Opioid abuse and addiction have taken a devastating toll on American families. We must do everything we can to make new, innovative treatment options available that can help patients regain control over their lives," said FDA Commissioner Robert M. Califf, M.D. "Today's approval provides the first-ever implantable option to support patients' efforts to maintain treatment as part of their overall recovery program."

Expanding the use and availability of medication-assisted treatment (MAT) options like buprenorphine is an important component of the FDA's opioid action plan and one of three top priorities for the U.S. Department of Health and Human Services' Opioid Initiative aimed at reducing prescription opioid and heroin related overdose, death and dependence.

Opioid dependence is the diagnostic term used for the more common concept, "addiction," in the Probuphine clinical trials. Addiction is defined as a cluster of behavioral, cognitive and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use, persisting in drug use despite harmful consequences, a higher priority given to drug use than to other activities and obligations, as well as the possibility of the development of tolerance or development of physical dependence. Physical dependence is not the same as addiction. Newer diagnostic terminology uses the term "opioid use disorder," which includes both milder forms of problematic opioid use as well as addiction.

MAT is a comprehensive approach that combines approved medications (currently, methadone, buprenorphine or naltrexone) with counseling and other behavioral therapies to treat patients with opioid use disorder. Regular adherence to MAT with buprenorphine reduces opioid withdrawal symptoms and the desire to use, without causing the cycle of highs and lows associated with opioid misuse or abuse. At sufficient doses, it also decreases the pleasurable effects of other opioids, making continued opioid abuse less attractive. According to the Substance Abuse and Mental Health Services Administration, patients receiving MAT for their opioid use disorder cut their risk of death from all causes in half.

"Scientific evidence suggests that maintenance treatment with these medications in the context of behavioral treatment and recovery support are more effective in the treatment of opioid use disorder than short-term detoxification programs aimed at abstinence," said Nora Volkow, M.D., director of the National Institute on Drug Abuse at the National Institutes of Health. "This product will expand the treatment alternatives available to people suffering from an opioid use disorder."

Probuphine should be used as part of a complete treatment program that includes counseling and psychosocial support. Probuphine consists of four, one-inch-long rods that are implanted under the skin on the inside of the upper arm and provide treatment for six months. Administering Probuphine requires specific training because it must be surgically inserted and removed. Only a health care provider who has completed the training and become certified through a restricted program called the Probuphine Risk Evaluation and Mitigation Strategy (REMS) program should insert and remove the implants. If further treatment is needed, new implants may be inserted in the opposite arm for one additional course of treatment. The FDA is requiring postmarketing studies to establish the safety and feasibility of placing the Probuphine implants for additional courses of treatment.

The safety and efficacy of Probuphine were demonstrated in a randomized clinical trial of adults who met the clinical criteria for opioid dependence and were considered stable after prior buprenorphine treatment. A response to MAT was measured by urine screening and self-reporting of illicit opioid use during the six month treatment period. Sixty-three percent of Probuphine-treated patients had no evidence of illicit opioid use throughout the six months of treatment – similar to the 64 percent of those who responded to sublingual (under the tongue) buprenorphine alone.

The most common side effects from treatment with Probuphine include implant-site pain, itching, and redness, as well as headache, depression, constipation, nausea, vomiting, back pain, toothache and oropharyngeal pain. The safety and efficacy of Probuphine have not been established in children or adolescents less than 16 years of age. Clinical studies of Probuphine did not include participants over the age of 65.

Probuphine has a boxed warning that provides important safety information for health care professionals, including a warning that insertion and removal of Probuphine are associated with the risk of implant migration, protrusion, expulsion and nerve damage resulting from the procedure. Probuphine must be prescribed and dispensed according to the Probuphine REMS program because of the risks of surgical complications and because of the risks of accidental overdose, misuse and abuse if an implant comes out or protrudes from the skin. As part of this program, Probuphine can only be prescribed and dispensed by health care providers who are certified with the REMS program and have completed live training, among other requirements.

Probuphine implants contain a significant amount of drug that can potentially be expelled or removed, resulting in the potential for accidental exposure or intentional misuse and abuse if the implant comes out of the skin. Patients should be seen during the first week after insertion and a visit schedule of no less than once-monthly is recommended for continued counseling and psychosocial support.

First buprenorphine implant for opioid dependence treatment gets FDA approval: The U.S. Food and Drug Administration today approved Probuphine, the first buprenorphine implant for the maintenance treatment of opioid dependence. Probuphine is designed to provide a constant, low-level dose of buprenorphine for six months in patients who are already stable on low-to-moderate doses of other forms of buprenorphine, as part of a complete treatment program.

Friday, November 20, 2015

FDA approves Endo’s BELBUCA (buprenorphine) buccal film for use in patients with chronic pain

New treatment option combines proven efficacy and established safety profile of buprenorphine with a novel delivery system that adds convenience and flexibility.

http://upload.wikimedia.org/wikipedia/commons/0/04/

Endo Pharmaceuticals Inc., a subsidiary of Endo International plc (NASDAQ: ENDP) (TSX: ENL), and BioDelivery Sciences International, Inc. (NASDAQ: BDSI), announced today that the U.S. Food and Drug Administration (FDA) has approved BELBUCA™ (buprenorphine) buccal film for use in patients with chronic pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.  BELBUCA™, which is the first and only buprenorphine developed with a dissolving film that is absorbed through the inner lining of the cheek for chronic pain management, is expected to be commercially available in the U.S. during the first quarter of 2016 in seven dosage strengths, allowing for flexible dosing ranging from 75 μg to 900 μg every 12 hours. This enables physicians to individualize titration and treatment based on the optimally effective and tolerable dose for each patient.

“The availability of new, convenient and flexible treatment options is important for patients whose lives are burdened by chronic pain, a debilitating condition that affects more Americans than diabetes, heart disease and cancer combined,” said Richard L. Rauck, M.D., Director of Carolinas Pain Institute, Winston Salem, NC. “BELBUCA™ provides a unique approach for chronic pain management, combining the proven efficacy and established safety of buprenorphine with a novel buccal film delivery system that adds convenience and flexibility. For both opioid-naïve and opioid-experienced patients who require around-the-clock treatment and for whom alternative treatment options are inadequate, BELBUCA™ offers appropriate, consistent pain relief and a low incidence of typical opioid-like side effects.”

BELBUCA™ is a mu-opioid receptor partial agonist and a potent analgesic with a long duration of action that utilizes BDSI’s patented BioErodible MucoAdhesive (BEMA®) drug delivery technology. Through this unique delivery system, buprenorphine is efficiently and conveniently delivered across the buccal mucosa (inside lining of the cheek). Buprenorphine is a Schedule III controlled substance, meaning that it has been defined as having lower abuse potential than Schedule II drugs, a category that includes most opioid analgesics. Among chronic pain patients taking opioids, the vast majority are on daily doses of 160 mg of oral morphine sulfate equivalent (MSE) or less. With seven dosage strengths up to 160 mg MSE, BELBUCA™ offers a treatment choice for a wide range of opioid needs in chronic pain sufferers.


Wednesday, February 12, 2020

Overdose, Relapse After Buprenorphine Discontinuation High


In continuation of my update on buprenorphine

Thumb

Buprenorphine treatment may be needed for several years after an opioid overdose to reduce the risk of overdose and other adverse events, according to a study published online Dec. 2 in The American Journal of Psychiatry.
Arthur Robin Williams, M.D., from the New York State Psychiatric Institute at the Columbia University Medical Center in New York City, and colleagues used the MarketScan multistate Medicaid claims database (2013 to 2017) to identify adults (18 to 64 years of age) who received buprenorphine continuously for ≥180 days. Outcomes were assessed by buprenorphine duration period (six to nine months, nine to 12 months, 12 to 15 months, and 15 to 18 months).
The researchers found that adverse events were common across all cohorts, and almost half of patients (42.1 to 49.9 percent) were seen in the emergency department at least once. Patients retained for 15 to 18 months (931 patients) had significantly lower odds of emergency department visits (odds ratio, 0.75), inpatient hospitalizations (odds ratio, 0.79), and filling opioid prescriptions (odds ratio, 0.67) in the six months following discontinuation, compared to patients retained on buprenorphine for six to nine months (4,126 patients). Across cohorts, approximately 5 percent of patients experienced one or more medically treated overdoses.
"Patients and families need guidance, social support, and better coordination of care to help facilitate long-term maintenance with buprenorphine for opioid use disorder," Williams said in a statement.
https://www.drugbank.ca/drugs/DB00921


Monday, December 31, 2018

Cassipa Approved for Opioid Dependence

In continuation of my update on buprenorphine and naloxone

Skeletal formula of buprenorphine                                           Naloxone.svg
Cassipa (buprenorphine and naloxone), a film designed to be placed under the tongue, has been approved to treat opioid dependence, the agency said in a news release.
Both buprenorphine and naloxone have been approved previously for this purpose.
"Opioid replacement therapy can be an important part of effective treatment," said FDA Commissioner Dr. Scott Gottlieb. "Opioid use disorder should be viewed similarly to any other chronic condition that is treated with medication."
The newly approved drug duo should be part of a complete treatment plan that includes counseling and psychosocial support to treat people with opioid use disorder. Cassipa may only be dispensed by approved prescribers, the agency said.
Side effects of the drugs include oral numbness, burning mouth, inflammation of the mouth's mucous membrane, headache, nausea, vomiting, excessive sweating and constipation.
Cassipa is produced by Teva Pharmaceuticals USA, based in New Jersey. Its parent company is located in Israel.
https://en.wikipedia.org/wiki/Buprenorphine
https://en.wikipedia.org/wiki/Naloxone

Wednesday, August 22, 2018

Alkermes Announces FDA Acceptance for Review of New Drug Application for ALKS 5461 for the Adjunctive Treatment of Major Depressive Disorder

In continuation of my update on ALKS-5461  .................
We know that, Buprenorphine/samidorphan (developmental code name ALKS-5461) is a combination drug formulation of buprenorphine and samidorphan acting as a μ-opioid receptor antagonist which is under development by Alkermes as an adjunct to antidepressant therapy in treatment-resistant depression (TRD).
Buprenorphine 
Buprenorphine and samidorphan.svg Samidorphan

Alkermes plc (Nasdaq: ALKS)announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for ALKS 5461, a novel, once-daily, oral investigational medicine for the adjunctive treatment of major depressive disorder (MDD) in patients with an inadequate response to standard antidepressant therapies. FDA's target action date for the ALKS 5461 NDA is Jan. 31, 2019.
FDA's acceptance of the ALKS 5461 NDA and rescission of the Refusal to File letter issued March 30, 2018 follows productive interactions with the Agency in which Alkermes clarified certain aspects of the NDA submission. No additional data or analyses were submitted by Alkermes to FDA.
"FDA's filing of the ALKS 5461 application is a positive step forward for patients suffering from major depressive disorder, a serious disease where inadequate response to existing antidepressants remains a well-known and significant treatment limitation, and where there have been no new pharmacological treatment approaches in 30 years," stated Craig Hopkinson, M.D., Chief Medical Officer and Senior Vice President of Medicines Development and Medical Affairs at Alkermes. "We will continue to engage with the FDA throughout the review process, as we work to bring this important medicine to patients."
The NDA filing for ALKS 5461 is based on results from a clinical efficacy and safety package with data from more than 30 clinical trials and more than 1,500 patients with MDD. Throughout the clinical development program, ALKS 5461 demonstrated a consistent profile of antidepressant activity, safety and tolerability in the adjunctive treatment of MDD.

Tuesday, March 12, 2019

Alkermes Receives Complete Response Letter From U.S. Food and Drug Administration for ALKS 5461 New Drug Application

In continuation f my update on ALKS 5461

Buprenorphine and samidorphan.svg



 Alkermes plc (Nasdaq: ALKS) announced that it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for ALKS 5461 for the adjunctive treatment of major depressive disorder (MDD). 
The CRL states that the FDA is unable to approve the ALKS 5461 NDA in its present form and is requesting additional clinical data to provide substantial evidence of effectiveness of ALKS 5461 for the adjunctive treatment of MDD. Alkermes plans to meet with the FDA to discuss the contents of the CRL and potential next steps for ALKS 5461. This interaction with the Agency will inform whether there is a viable path forward for the ALKS 5461 program.
The NDA submission for ALKS 5461 was based on results from a clinical efficacy and safety package with data from more than 30 clinical trials and more than 1,500 patients with MDD. Throughout the clinical development program, ALKS 5461 demonstrated a consistent profile of antidepressant activity, safety and tolerability in the adjunctive treatment of MDD.

About ALKS 5461

ALKS 5461 is a proprietary, investigational, once-daily oral medicine that acts as an opioid system modulator and represents a novel mechanism of action for the adjunctive treatment of major depressive disorder (MDD) in patients with an inadequate response to standard antidepressant therapies. ALKS 5461 is a fixed-dose combination of buprenorphine, a partial mu-opioid receptor agonist and kappa-opioid receptor antagonist, and samidorphan, a mu-opioid receptor antagonist.

About Major Depressive Disorder (MDD)

According to the DSM-5® (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition), major depressive disorder (MDD) is a condition in which patients exhibit depressive symptoms, such as a depressed mood or a loss of interest or pleasure in daily activities consistently for at least a two-week period, and demonstrate impaired social, occupational, educational or other important functioning. An estimated 16.2 million people in the U.S. suffered from MDD in 2016,1 the majority of whom may not adequately respond to initial antidepressant therapy.
https://en.wikipedia.org/wiki/Buprenorphine/samidorphan

Tuesday, December 1, 2015

BDSI announces FDA approval of BUNAVAIL sNDA for manufacturing specification change



https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjevkEiQZzMMsBVoxKSUsKTZc-Y16dTZYBo8cTqxtxFsQAw7mpzJKxfvviz9JBIwg7AS5JElI7s6c00oWTcRGyp3PG1oMY6VlU02NWkFjQ21v2RaM4dzXhxGS6jizQV74QS1HSFgKea69I/s1600/


BioDelivery Sciences International, Inc. (NASDAQ: BDSI) announced that the U.S. Food and Drug Administration (FDA) has approved the company's Supplemental New Drug Application (sNDA) for a manufacturing specification change for BUNAVAIL® (buprenorphine and naloxone) buccal film (CIII).


The approval allows for the immediate release of BUNAVAIL inventory to wholesalers. BDSI will be shipping product to wholesalers this morning which should make product available in pharmacies as early as Friday.
The newly released product supplies are expected to satisfy current and anticipated demand, which has increased following the October 1 initiation of a contract providing exclusive, preferred formulary status for BUNAVAIL for Medicaid patients in the state of Tennessee.

"All of us at BDSI want to thank the Division of Anesthesia, Analgesia and Addiction Products at FDA for working with us in an expeditious and collaborative fashion to help allow patients benefiting from BUNAVAIL treatment to maintain uninterrupted availability," said Dr. Mark A. Sirgo, President and Chief Executive Officer. "We also want to thank all of the patients, physicians and other health providers, including pharmacists, for their patience and support during this period of inconvenience."