FDA panel recommends approval of Teva’s abuse-deterring opioid, despite reservations

FDA

A FDA panel has recommended the approval of Teva's ($TEVA) long-acting opioid. The 14-3 vote in favor of the drug followed a discussion in which members of the panel flagged up concerns with the extent to which the product lives up to its “abuse-resistant” tag.

FDA convened the panel to assess whether Teva should be allowed to make a label claim regarding the ability of its painkiller to deter abuse. While the majority of the panel ultimately decided Teva’s product, Vantrela ER, may cut the risk of abuse through swallowing, snorting or injecting of the drug, the overall feeling was that it represents, at best, an incremental gain, rather than the long-hoped-for answer to the problem of opioid misuse.

“The committee's belief is that the data presented for all three of these routes of administration do show at least a modicum of abuse deterrence,” Dr. Raeford Brown Jr., the chair of the panel and a professor of anesthesiology and pediatrics at the University of Kentucky, said, according to Reuters. If FDA concurs with the decision of the panel, that muted support would be sufficient for Teva to win approval of a product tipped by analysts at Mizuho Securities USA to hit annual sales of $130 million.

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One alternative scenario is that FDA, which is under pressure from members of Congress to get on top of opioid abuse, goes against the panel and rejects the drug. There is precedent for FDA rejecting the recommendations of advisory panels. And, with at least one panelist seeing Vantrela ER as “just another high-dose drug” in a sea of similar painkillers that are already on the market, FDA would have the support of some of the experts if it took such an action.

Dr. Jeanmarie Perrone, the professor of emergency medicine at the University of Pennsylvania who made the “just another high-dose drug”, is unconvinced by the abuse-resistant properties of Teva’s product. “[Patients taking the drug orally] may still feel euphoria just by taking a bigger dose at one time,” Perrone said at the panel. A preliminary review published by FDA last week also raised doubts about the extent to which Vantrela ER prevents abuse when taken orally.

The panel will now move on to assessing Pfizer’s ($PFE) rival long-acting opioid. Again, early signs are that the drug is far from the panacea of the opioid crisis. An initial review released by FDA early this week found it is possible to extract the semisynthetic opioid oxycodone from Pfizer’s product using solvents, raising the possibility that addicts will be able to bypass its abuse-deterring properties. The panel is due to discuss Pfizer’s drug today.

- read Reutersarticle

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