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buprenorphine

This page shows the latest buprenorphine news and features for those working in and with pharma, biotech and healthcare.

Alkermes slumps as FDA turns down depression drug

Alkermes slumps as FDA turns down depression drug

The US regulator issued a ‘refusal to file’letter to the company yesterday for the drug, which is a fixed-dose combination of buprenorphine, an opioid used for many years to

Latest news

  • FDA panel backs Indivior’s drug to fight opioid addiction FDA panel backs Indivior’s drug to fight opioid addiction

    That would help counteract a major setback for the business in the US a few weeks back when it lost a patent infringement lawsuit involving its main product Suboxone (buprenorphine and ... emergency, while FDA Commissioner Scott Gottlieb has announced

  • CHMP backs maintenance therapy for Tesaro's Zejula CHMP backs maintenance therapy for Tesaro's Zejula

    Also given the nod were two drugs from Mundipharma intended to help people with opioid addiction – Nyxoid (naloxone) and Zubsolv (buprenorphine/naloxone), while Spanish drugmaker Grifols got the go-ahead for

  • Indivior slumps as patent dispute rises US generic spectre Indivior slumps as patent dispute rises US generic spectre

    The UK-listed company - which was spun out of Reckitt Benckiser three years ago - generates the bulk of its revenues from Suboxone (buprenorphine and naloxone), an oral film product used for ... of buprenorphine for treating opioid dependence.

  • FDA gives green light for opioid addiction implant FDA gives green light for opioid addiction implant

    The biannually administered implant provides a constant, low-level dose of buprenorphine, and is intended for use as part of a maintenance treatment programme for patients already stable on

  • Alkermes depression drug misses targets in phase III Alkermes depression drug misses targets in phase III

    ALKS 4561 is a once-daily oral formulation of two drugs - mu opioid receptor antagonist samidorphan and mixed mu agonist/kappa antagonist buprenorphine - and represents a completely new approach to treating ... depression. Buprenorphine is thought to

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  • Pharma deals during December 2012 Pharma deals during December 2012

    deal? Coincidentally, the third late stage deal this month is also an analgesic, a buprenorphine implant lasting for six months for maintenance treatment of opioid dependence; the NDA was submitted in ... 335. Titan / Braeburn. Commercialisation and

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