Abuse-Deterrent Oxycodone Rejected by FDA
FDA requests additional evidence to prove oxycodone hydrochloride extended-release tablets' abuse-deterrent potential for oral and nasal routes of administration.
Officials with the FDA have rejected Intellipharmaceutics’ abuse-deterrent Oxycodone Hydrochloride Extended-Release Tablets (Rexista), the company announced in a press release.
A Complete Response Letter (CRL) from the agency stated that further evidence is needed to prove the drug’s abuse-deterrent potential for oral and nasal routes of administration. The FDA has requested that Intellipharmaceutics’ complete the relevant category 2 and category 3 studies to assess the abuse-deterrent properties by these types of administration. Additionally, the FDA has requested for more information related to the abuse-deterrent properties of the blue dye included in Oxycodone ER’s formulation.
In July 2017, members of the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Committee voted 22-1 against recommending Rexista for approval. FDA officials raised concerns about inadequate data on the product’s abuse potential.
The committee also voted 19-4 in finding that Intellipharmaceutics’ has not demonstrated that Oxycodone ER’s properties can be expected to deter abuse by intravenous route of administration.
The company has 1 year to respond to the CRL, although it can request additional time if necessary. Intellipharmaceutics has also been asked to submit an alternate proposed proprietary name for Oxycodone ER.
“We will continue to work closely with the FDA to provide them with the additional information they requested, including data supporting the label claims related to oxycodone ER’s abuse-deterrent properties,” Intellipharmaceutics CEO Isa Odidi, PhD, said in the press release.
In this video from PainWeek 2017, Jeremy Adler, MS, PA-C, co-owner of Pacific Pain Medicine, discusses the mechanisms by which abuse-deterrent opioids prevent misuse.
Reference
Intellipharmaceutics Receives Complete Response Letter from the FDA for Rexista NDA [news release]. Toronto. Intellipharmaceutics’ website. http://www.intellipharmaceutics.com/releases.cfmAccessed September 25, 2017.
