FDA Panel Does Not Recommend Approval of Abuse-Deterrent Opioid

July 26th 2017

In a company press release, Intellipharmaceutics announced that an FDA panel voted against recommending its abuse-deterrent oxycodone hydrochloride extended release tablets, Rexista, for approval.

Rexista is designed as an abuse-deterrent version of OxyContin.

Members of the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Committee indicated that the company failed to conduct studies advised by the FDA’s abuse-deterrent opioid development guidelines. The panel voted 22-1 against approving Rexista. In a preliminary review on Monday, FDA officials raised concerns about inadequate data on the product’s abuse potential.

The panelists pointed to the lack of any human studies to provide evidence of the painkiller’s safety and efficacy.

The committee also voted 19 to 4 in finding that the company has not demonstrated that Rexista has properties that can be expected to deter abuse by intravenous route of administration. Additionally, the committee noted that there are not sufficient data to support including a label that shows it has abuse deterrent properties for intravenous administration.

According to Intellipharma’s press release, company officials plan to conduct a human abuse potential study for the intranasal route of abuse in the coming weeks.

Reference

Intellipharmaceutics Provides Update on FDA Advisory Committees Meeting for Rexista (oxycodone hydrochloride extended release), an Abuse-Deterrent Opioid Analgesic for the Treatment of Moderate to Severe Pain [news release]. Toronto. Intellipharma’s website.

. Accessed July 27, 2017.

http://www.intellipharmaceutics.com/releases.cfm

FDA. Joint Meeting of Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee. 2017.

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Accessed July 27, 2017.

In a company press release, Intellipharmaceutics' announced that an FDA panel voted against recommending its abuse-deterrent oxycodone hydrochloride extended release tablets, Rexista, for approval.https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AnestheticAndAnalgesicDrugProductsAdvisoryCommittee/UCM568075.pdf

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