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FDA committee rejects Intellipharmaceutics’ opioid drug Aximris

Verdict closely follows rejection of Nektar’s opioid analgesic

FDA

The FDA’s Anesthetic and Analgesic Committee has rejected yet another opioid drug – this time Intellipharmaceutics’ extended-release oxycodone tablet Aximiris. 

Oxycodone is the active ingredient of recently bankrupted Purdue Pharma’s OxyContin, a drug which had taken much of the brunt of blame for the opioid addiction epidemic in the US.

Aximris was developed as an abuse and alcohol-deterrent controlled-release oral formulation of oxycodone hydrochloride for pain relief.

Intellipharmaceutics had been seeking approval for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment, for which alternative treatment options are inadequate.

The FDA committee panel voted 24 to 2 against the approval of Aximris in this indication. Given the clinical make-up of the drug, the FDA compared its abuse-deterrent properties to OxyContin.

Despite finding that the “results demonstrate that Aximris XR would be an effective ER opioid analgesic with important improvements in abuse deterrence for the IV route”, the FDA had concerns that its formulation may be more susceptible to intranasal abuse than existing products.

Proving the benefits of new opioid products to the FDA is becoming increasingly difficult – the same FDA panel also unanimously rejected Nektar Therapeutic’s NKTR-181, an opioid analgesic for chronic back pain.

The committee cited concerns that the drug carries with it a risk of misuse and addiction, and also took issue with a lack of data regarding the drugs susceptibility to intranasal abuse.

A number of pharma companies in the US have recently faced legal scrutiny for their part in fuelling an opioid epidemic in the country, which various state officials say was driven by dishonest marketing strategies and misleading information pushed by the pharmaceutical industry.

In England and Wales, prescriptions for opioid medicines have risen from around £14m in 2008 to around £23m in 2018. During the same time period, the number of codeine-related deaths in England and Wales doubled to more than 150.

Last year, Health Secretary Matt Hancock announced measure to counteract possible misuse of these drugs, by introducing mandatory warning labels on all opioid medicines in the UK.

For Intellipharmaceutics, the status of Aximris is now quite bleak – in a statement, the company said “there can be no assurance that the FDA will ultimately approve the NDA for the sale of Aximris in the US market, or that it will ever be successfully commercialised”.

Article by
Lucy Parsons

17th January 2020

From: Regulatory

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