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    • Remoxy

Remoxy Newsletter
  • Benzinga's Daily Biotech Pulse: Epidiolex, Roche's Influenza Drug Gets Priority Review Status, Xeris Jumps On Positive Trial Results 26 Jun 2018 13:04 GMT

    … Pharmaceuticals Inc (NASDAQ: MACK)(on failed trial results for its pancreatic cancer treatment … FDA-Approved Drug The FDA approved GW Pharmaceuticals PLC … In Biotech: Conferences, Clinical Trials And IPOs … NDA for remoxy, oxycodone extended-release capsules …

  • Pain Therapeutics Announces Feedback from Recent Meeting with FDA on REMOXY 05 Feb 2019 13:00 GMT

    … . Food and Drug Administration (FDA) regarding the drug candidate, REMOXY ER.  REMOXY is the trade … , extended-release gel formulation of oxycodone (CII) with physical/ … , in which similar drugs receive similar regulatory treatment under rules that are …

  • Pain Therapeutics Appeals FDA Decision on REMOXY 12 Nov 2018 12:30 GMT

    … & Drug Administration (FDA) regarding a Complete Response Letter (CRL) for REMOXY issued … August 2018.  The FDA and the Company … Opioid Abuse Opioid drugs such as oxycodone are an important treatment option for …

  • Pain Therapeutics Announces Results of FDA Advisory Committee Meeting for REMOXY ER 26 Jun 2018 21:35 GMT

    … for which alternative treatment options are inadequate. REMOXY ER, the Company’s … of oxycodone, a widely prescribed opioid medication.  The FDA has set a Prescription Drug … Opioid Abuse Opioid drugs such as oxycodone are an important treatment option for …

  • Complete Response Letter Issued for REMOXY™ 06 Aug 2018 11:00 GMT

    … . Food and Drug Administration (FDA) for its New Drug Application (NDA) for REMOXY, an … -in-class abuse deterrence versus OxyContin.  We relied on the criteria … ;s could allow treatment to start sooner, optimize treatment options for each …

  • Pain Therapeutics Can't Catch A Break With The FDA, Opioid Drug Rejected Yet Again 07 Aug 2018 19:39 GMT

    … its pain drug Remoxy. It seems that the biotech has finally … Pain Therapeutics after its latest FDA rejection. If there was … who runs the Biotech Analysis Central pharmaceutical investment research service on … a two-week free trial period for subscribers to …

  • FDA Snubs PTIE Again, OVID's STARS Fail To Shine, HAIR Keeps Falling 07 Aug 2018 03:13 GMT

    … of the pharma/biotech stocks that posted the biggest … investigational pain drug Remoxy ER has been rejected by the FDA again. This … its phase II trial of OV101 for the treatment of Angelman … of common stock. 4. Citius Pharmaceuticals Inc. (CTXR) Lost 17. …

  • FDA Decision Sends Pain Therapeutics Reeling 06 Aug 2018 21:43 GMT

    … Drug Administration for Remoxy’s New Drug Application. What Happened The FDA … , extended-release form of oxycodone, Remoxy was Pain Therapeutics’ answer … a profound need for new treatments," Barbier said. … #39;s Phase 2 Trials Are An Entry Point For …

  • FDA Decision Sends Pain Therapeutics, Durect Corp. Reeling 06 Aug 2018 20:17 GMT

    … Drug Administration for Remoxy’s New Drug Application. What Happened The FDA … , extended-release form of oxycodone, Remoxy was Pain Therapeutics’ answer … a profound need for new treatments," Barbier said. … #39;s Phase 2 Trials Are An Entry Point For …

  • FDA declines to approve Pain Therapeutics' opioid drug,... 06 Aug 2018 16:44 GMT

    … #39;s abuse-deterrent opioid treatment Remoxy for the fourth time, sending … commonly used opioid oxycodone, and the high-viscosity drug mass helped … be shared within weeks. The FDA's decision comes … an advisory panel to the FDA concluded that while the …

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