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FDA panel backs Pfizer and Teva abuse-resistant painkillers

Recommends long-acting opioid analgesics Troxyca ER and Vantrela ER for approval

An FDA advisory committee has recommended approval of two long-acting opioid analgesics from Teva and Pfizer designed to resist abuse.

The panel voted by 14 to 3 in favour of approving Teva's Vantrela ER (hydrocodone bitartrate) for "the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate".

As part of the approval it also backed label claims that the Vantrela ER formulation can help to prevent abuse by the oral, intravenous and intranasal routes.

The panel also voted by nine votes to six in favour of approving Pfizer's Troxyca ER (oxycodone/naltrexone) for the sane indication. However, it would not back a label claim that the product could prevent abuse of the drug via the oral route, but said it could discourage abuse by people seeking to inject or snort the drug.

The two products are aimed at a market estimated to be worth around $2.5bn with several abuse-resistant products already on the market including Purdue Pharma's Hysingla ER and Pernix Therapeutics' Zohydro ER.

Vantrela ER uses a layering technology in its formulation that prevents hydrocodone being released in sufficiently high concentrations for abusers to achieve a high if the tablets are crushed. In the case of Troxyca ER, the inclusion of opioid blocker naltrexone is designed to achieve the same end result.

Committee members were swayed by the FDA reviewer's report on Troxyca ER however, which concluded that it was possible for addicts to extract oxycodone from the pills using solvents.

Last month the same panel also rejected an abuse-deterrent claim for KemPharm's Apadaz (benzhydrocodone hydrochloride and acetaminophen) whilst backing approval of the drug. Yesterday the company filed an amendment request with the FDA seeking time to build its case for an abuse claim.

More than 165,000 people died in the US from overdoses related to prescription opioids between 1999 and 2014. Opioid prescribing continues to fuel the epidemic as at least half of all opioid overdose deaths in the country involve a prescription opioid.

Pfizer already sells an abuse-resistant formulation of morphine called Embeda, which uses the same naltrexone technology and was awarded an oral and intranasal abuse claim in 2014, but without an intravenous abuse claim.

The company secured rights to Troxyca ER (also known as ALO-02) when it acquired King Pharmaceuticals in 2010 for $3.6bn.

It also gained rights to two other abuse-deterrent formulations from that deal - Remoxy (oxycodone) and Oxecta (hydrocodone) - but handed rights back to their original developers, Durect/Pain Therapeutics and Acura, respectively.

Remoxy has been rejected twice by the FDA but the agency has just accepted a resubmitted marketing application for and is due to deliver a verdict on the drug by 25 September.

Article by
Phil Taylor

10th June 2016

From: Regulatory



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