Food and drug administration Panel Doesn’t Recommend Abuse-Deterrent Form of OxyContin for Approval

An Food and drug administration panel voted against recommending Intellipharmaceutics’ Rexista abuse-deterrent oxycodone hydrochloride extended release tablets, based on a business pr release. Rexista was created being an abuse-deterrent form of OxyContin.

People from the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Committee established that the organization unsuccessful to conduct studies advised through the FDA’s abuse-deterrent opioid development guidelines. The panel voted 22-1 against approving Rexista.  In an initial review on Monday, Food and drug administration officials elevated concerns about insufficient data around the product’s abuse potential.

The panelists pointed to the possible lack of any scientific testing on people to supply proof of the painkiller’s safety and effectiveness.

The committee also voted 19 to 4 to find that the organization hasn’t shown that Rexista has qualities that may be likely to deter abuse by intravenous route of administration. Furthermore, the committee noted there are not sufficient data to aid together with a label that shows it’s abuse deterrent qualities for intravenous administration.

Based on Intellipharma’s pr release, company officials intend to conduct an individual abuse potential study for that intranasal route of abuse within the coming days.

Reference

Intellipharmaceutics Provides Update on Food and drug administration Advisory Committees Meeting for Rexista (oxycodone hydrochloride extended release), an Abuse-Deterrent Opioid Analgesic to treat Moderate to Severe Discomfort [news release]. Toronto. Intellipharma’s website. http://world wide web.intellipharmaceutics.com/releases.cfm. Utilized This summer 27, 2017.

Food and drug administration. Joint Meeting of Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee. 2017. https://world wide web.food and drug administration.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AnestheticAndAnalgesicDrugProductsAdvisoryCommittee/UCM568075.pdf. Utilized This summer 27, 2017.

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