Buprenorphine

Indivior Preliminary Injunction on Generic (buprenorphine and naloxone) Sublingual Film Upheld

Retrieved on: 
Tuesday, July 31, 2018
Chemistry, RTT, Cell signaling, Morphinans, Signal transduction, Drug rehabilitation, Opioid antagonists, Alcohols, Buprenorphine/naloxone, Buprenorphine, Indivior, Naloxone

The PI prohibits DRL from using, importing, selling, or offering to sell its generic buprenorphine/naloxone sublingual film product.

Key Points: 
  • The PI prohibits DRL from using, importing, selling, or offering to sell its generic buprenorphine/naloxone sublingual film product.
  • Indivior is dedicated to transforming addiction from a global human crisis to a recognized and treated chronic disease.
  • You should not drink alcohol while taking SUBOXONE Film, as this can lead to loss of consciousness or even death.
  • For more information about SUBOXONE Film, SUBOXONE (buprenorphine and naloxone) Sublingual Tablets (CIII), or SUBUTEX (buprenorphine) Sublingual Tablets (CIII), please see the respective full Prescribing Information and Medication Guide at www.suboxoneREMS.com .

Camurus Announces PDUFA Date for CAM2038 for the Treatment of Opioid use Disorder

Retrieved on: 
Monday, July 16, 2018
Chemistry, Cell signaling, Morphinans, RTT, Neurochemistry, Drug rehabilitation, Opioid antagonists, Alcohols, Buprenorphine, Opioid use disorder, Camurus, Naloxone

"We are pleased that the FDA has assigned a target action date for a US approval decision for CAM2038 in Q4 2018," said Fredrik Tiberg, President and CEO of Camurus.

Key Points: 
  • "We are pleased that the FDA has assigned a target action date for a US approval decision for CAM2038 in Q4 2018," said Fredrik Tiberg, President and CEO of Camurus.
  • "This is an important step for Camurus and our commitment to providing people living with opioid dependence worldwide with a new, flexible, long-acting treatment option.
  • If approved, CAM2038 would be the first long-acting treatment for OUD available in both weekly and monthly formulations for use through all stages of a patient's treatment journey.
  • Weekly and monthly subcutaneous buprenorphine depot formulations vs daily sublingual buprenorphine with naloxone for treatment of opioid use disorder: A randomized clinical trial.

Camurus Announces PDUFA Date for CAM2038 for the Treatment of Opioid use Disorder

Retrieved on: 
Monday, July 16, 2018
Chemistry, Cell signaling, Morphinans, RTT, Neurochemistry, Drug rehabilitation, Opioid antagonists, Alcohols, Buprenorphine, Opioid use disorder, Camurus, Naloxone

"We are pleased that the FDA has assigned a target action date for a US approval decision for CAM2038 in Q4 2018," said Fredrik Tiberg, President and CEO of Camurus.

Key Points: 
  • "We are pleased that the FDA has assigned a target action date for a US approval decision for CAM2038 in Q4 2018," said Fredrik Tiberg, President and CEO of Camurus.
  • "This is an important step for Camurus and our commitment to providing people living with opioid dependence worldwide with a new, flexible, long-acting treatment option.
  • If approved, CAM2038 would be the first long-acting treatment for OUD available in both weekly and monthly formulations for use through all stages of a patient's treatment journey.
  • Weekly and monthly subcutaneous buprenorphine depot formulations vs daily sublingual buprenorphine with naloxone for treatment of opioid use disorder: A randomized clinical trial.

Zubsolv® Now Launched in the EU, Which Triggers a EUR 3m Milestone Payment to Orexo

Retrieved on: 
Monday, June 18, 2018
Chemistry, Cell signaling, Morphinans, RTT, Signal transduction, Opioid antagonists, Drug rehabilitation, Alcohols, Naloxone, Buprenorphine

The launch is triggering a milestone payment of EUR 3 million from Mundipharma.

Key Points: 
  • The launch is triggering a milestone payment of EUR 3 million from Mundipharma.
  • [2]
    "Taking the step out in Europe, is yet another important milestone for Orexo.
  • Zubsolv will be an affordable and user-friendly treatment and the first therapy in Europe with a choice of up to six different strengths.
  • The main market today is the American market for buprenorphine/naloxone products, where Orexo sells the product Zubsolv.

Dr. Reddy's Laboratories announces USFDA final approval and launch of Buprenorphine and Naloxone Sublingual Film in the U.S. Market

Retrieved on: 
Friday, June 15, 2018
Chemistry, RTT, Cell signaling, Morphinans, Organic chemistry, Alcohols, Drug rehabilitation, Opioid antagonists, Buprenorphine, Naloxone, Buprenorphine/naloxone, Opioid use disorder

Injecting Buprenorphine and Naloxone Sublingual Film may cause serious withdrawal symptoms such as pain, cramps, vomiting, diarrhea, anxiety, sleep problems, and cravings.

Key Points: 
  • Injecting Buprenorphine and Naloxone Sublingual Film may cause serious withdrawal symptoms such as pain, cramps, vomiting, diarrhea, anxiety, sleep problems, and cravings.
  • Do not take Buprenorphine and Naloxone Sublingual Film if you are allergic to buprenorphine or naloxone.
  • What should I tell my healthcare provider before taking Buprenorphine and Naloxone Sublingual Film?
  • Before taking Buprenorphine and Naloxone Sublingual Film, tell your doctor if you currently have or are:

FDA approves first generic versions of Suboxone sublingual film, which may increase access to treatment for opioid dependence

Retrieved on: 
Thursday, June 14, 2018
Chemistry, Cell signaling, Morphinans, RTT, Neurochemistry, Alcohols, Drug rehabilitation, Opioid antagonists, Buprenorphine, Naloxone, Food and Drug Administration, Opioid use disorder

That includes promoting the development of better drugs, and also facilitating market entry of generic versions of approved drugs to help ensure broader access," said FDA Commissioner Scott Gottlieb, M.D.

Key Points: 
  • That includes promoting the development of better drugs, and also facilitating market entry of generic versions of approved drugs to help ensure broader access," said FDA Commissioner Scott Gottlieb, M.D.
  • When coupled with other social, medical and psychological services, medication-assisted treatments are often the most effective approach for opioid dependence."
  • One of the ways the FDA is encouraging access and wider use of MAT is through the approval of generic versions of these products.
  • Buprenorphine and naloxone sublingual film should be used as part of a complete treatment plan that includes counseling and psychosocial support.

Emergency Departments Help Close Gaps in Opioid Abuse and Addiction Treatment

Retrieved on: 
Thursday, June 14, 2018
Chemistry, RTT, Cell signaling, Morphinans, Neurochemistry, Substance dependence, Drug rehabilitation, Ethers, Buprenorphine, Opioid use disorder, Opioid, Addiction

MAT refers to addiction treatment with medications, most commonly buprenorphine, although it is most effective when combined with behavioral therapy and counseling.

Key Points: 
  • MAT refers to addiction treatment with medications, most commonly buprenorphine, although it is most effective when combined with behavioral therapy and counseling.
  • Coordinated care for complex chronic conditions is proven to be effective; treating opioid use disorder should be no different."
  • The authors make recommendations for opioid abuse screening, treatment and referrals in the emergency department.
  • Annals of Emergency Medicineis the peer-reviewed scientific journal for the American College of Emergency Physicians, the national medical society representing emergency medicine.

Titan Pharmaceuticals And Braeburn Announce Mutual Termination Of License Agreement For Probuphine® For Opioid Dependence

Retrieved on: 
Wednesday, May 30, 2018
Cell signaling, Morphinans, Neurochemistry, Drug rehabilitation, Chemistry, RTT, Ethers, Phenols, Buprenorphine, Opioid use disorder, Opioid, Substance dependence

Under the terms of the termination agreement, Titan will regain all rights to the commercialization and clinical development of Probuphine in the U.S. and Canada.

Key Points: 
  • Under the terms of the termination agreement, Titan will regain all rights to the commercialization and clinical development of Probuphine in the U.S. and Canada.
  • In addition, the parties will immediately transfer to Titan all regulatory documentation and development data related to Probuphine.
  • "Meanwhile, we will ensure that Probuphine will continue to be available through established distribution channels for patients suffering from opioid use disorder."
  • The company's lead product is Probuphine, a novel and long-acting formulation of buprenorphine for the long-term maintenance treatment of opioid dependence.

Aquestive Therapeutics Settles Patent Infringement Case with Par Pharmaceuticals

Retrieved on: 
Friday, May 18, 2018
Chemistry, Cell signaling, Morphinans, RTT, Signal transduction, Opioid antagonists, Drug rehabilitation, Alcohols, Indivior, Buprenorphine/naloxone, Naloxone, Buprenorphine

In the news release, Aquestive Therapeutics Settles Patent Infringement Case with Par Pharmaceuticals, issued 14-May-2018 by Aquestive Therapeutics over PR Newswire, we are advised by the company that the second paragraph, first sentence, should read " Under the settlement agreement, Par Pharmaceuticals and IntelGenx are permitted to launch their proposed generic version of the buprenorphine and naloxone sublingual film on January 1, 2023, or earlier under certain circumstances" rather than "Under the settlement agreement, Par Pharmaceuticals and IntelGenx agreed to launch their proposed generic version of the buprenorphine and naloxone sublingual film no earlier than January 1, 2023" as originally issued inadvertently.

Key Points: 
  • In the news release, Aquestive Therapeutics Settles Patent Infringement Case with Par Pharmaceuticals, issued 14-May-2018 by Aquestive Therapeutics over PR Newswire, we are advised by the company that the second paragraph, first sentence, should read " Under the settlement agreement, Par Pharmaceuticals and IntelGenx are permitted to launch their proposed generic version of the buprenorphine and naloxone sublingual film on January 1, 2023, or earlier under certain circumstances" rather than "Under the settlement agreement, Par Pharmaceuticals and IntelGenx agreed to launch their proposed generic version of the buprenorphine and naloxone sublingual film no earlier than January 1, 2023" as originally issued inadvertently.
  • The complete, corrected release follows:
    WARREN, N.J., May 18, 2018 /PRNewswire/ --Aquestive Therapeutics, Inc., today announced a settlement agreement has been reached resolving patent litigation related to SUBOXONE (buprenorphine and naloxone) Sublingual Film.
  • Indivior PLC and its U.S. subsidiary, Indivior Inc., marketers and distributors of SUBOXONE, joined partner Aquestive in the settlement with Par Pharmaceuticals, Inc., an operating company of Endo International PLCand IntelGenx Technologies Corp.
  • Aquestive Therapeutics is a specialty pharmaceutical company focused on identifying, developing and commercializing differentiated products to address unmet medical needs.

Indivior Enters into Settlement with Par Pharmaceutical in Patent Infringement Case

Retrieved on: 
Monday, May 14, 2018
Chemistry, Cell signaling, Morphinans, RTT, Signal transduction, Drug rehabilitation, Opioid antagonists, Alcohols, Indivior, Buprenorphine/naloxone, Buprenorphine, Naloxone

SLOUGH, England, May 14, 2018 /PRNewswire/ --Indivior PLC (LON: INDV) ("Indivior" or the "Company") today announced that its U.S. subsidiary, Indivior Inc., together with Aquestive Therapeutics, Inc. (formerly known as Monosol Rx, LLC), entered into a settlement agreement with Par Pharmaceutical Inc., Par Pharmaceutical Companies Inc., Endo International PLC (collectively, "Par") and IntelGenx Technologies Corp., resolving patent litigation related to SUBOXONE (buprenorphine and naloxone) Sublingual Film.

Key Points: 
  • SLOUGH, England, May 14, 2018 /PRNewswire/ --Indivior PLC (LON: INDV) ("Indivior" or the "Company") today announced that its U.S. subsidiary, Indivior Inc., together with Aquestive Therapeutics, Inc. (formerly known as Monosol Rx, LLC), entered into a settlement agreement with Par Pharmaceutical Inc., Par Pharmaceutical Companies Inc., Endo International PLC (collectively, "Par") and IntelGenx Technologies Corp., resolving patent litigation related to SUBOXONE (buprenorphine and naloxone) Sublingual Film.
  • The settlement permits Par to begin selling a generic version of SUBOXONE Film on January 1, 2023, or earlier under certain circumstances.
  • Shaun Thaxter, CEO of Indivior, said, "We are pleased to have amicably settled another piece of outstanding patent infringement litigation.
  • Indivior is dedicated to transforming addiction from a global human crisis to a recognized and treated chronic disease.