Intellipharmaceutics said an FDA advisory committee voted 24-2 against approval of its abuse-deterrent opioid analgesic Aximris XR (oxycodone extended-release), driving shares down as much as nearly 80% on Thursday. The company is seeking approval of the drug for pain severe enough to require daily, around-the-clock, long-term opioid treatment in patients who have inadequate alternative options.
The FDA issued a complete response letter for the drug, previously known as Rexista, in 2017. At the time, the US regulator had asked for additional information, including that Intellipharmaceutics complete certain studies evaluating the drug's abuse-deterrent properties by the oral and nasal routes of administration. The agency also asked Intellipharmaceutics to propose another name for the treatment. A filing was resubmitted in 2019, with an FDA decision initially expected last August.
However, the advisory committee meeting for Aximris XR, as well as all other product-specific advisory meetings for opioid analgesics, was postponed while the FDA conducted a review into how it evaluates new applications for the drug class. Aximris XR is intended as an abuse and alcohol-deterrent controlled-release oral formulation of oxycodone, presenting a barrier to tampering when subjected to various forms of physical and chemical manipulation, while it is also designed to prevent dose dumping when inadvertently co-administered with alcohol. The formulation is designed to coagulate and entrap the drug in a viscous material if it is crushed or pulverised and hydrated.
The FDA advisory committee also voted 13-13 over whether to approve Esteve's E-58425, a combination of the opioid tramadol and the anti-inflammatory drug celecoxib, for moderate-to-severe acute pain. In addition, earlier this week, FDA advisors voted against approval of Nektar Therapeutics' opioid pain drug NKTR-181 to treat adults suffering from severe chronic low back pain, citing safety concerns and lack of data. The company has since decided to withdraw the drug's marketing application and said it would make no further investment into the programme.
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