Shares of Pain Therapeutics, Inc. (PTIE - Free Report) and partner, Durect Corp. , plunged following the news that a joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee, and Drug Safety and Risk Management Advisory Committee of the FDA voted 14 to 3 against the approval of pain drug, Remoxy ER.
Per the company, Remoxy is a new type of abuse-deterrent, extended-release, oral formulation of widely used opioid drug oxycodone. It is being evaluated 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.
The news disappointed investors as Remoxy ER is Pain Therapeutics’ lead candidate. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of Aug 7, 2018 for completion of its review of the New Drug Application (NDA) for Remoxy ER.
The NDA is requesting label claims for abuse deterrence against three routes of abuse: injection, inhalation and nasal. Per the company, Remoxy’s thick, sticky, high viscosity formulation may deter unapproved routes of drug administration, such as injection, snorting or smoking.
However, given the committee’s negative opinion on the formulation, a positive outcome from the FDA review is highly unlikely.
Pain Therapeutics’ shares have lost 39.1% so far in 2018 compared to the industry’s gain of 0.4%. Shares lost 70% of their value on the above-mentioned news.
We note that Pain Therapeutics has a license agreement with Durect to use the latter’s Oradur technology for Remoxy. While Pain Therapeutics is solely responsible for clinical development, Durect is responsible for furnishing suitable laboratory facilities, equipment and personnel, during pre-clinical phases of development. Both the companies are jointly responsible for certain pre-clinical activities. Pain Therapeutics is obligated to pay royalties to Durect on commercial sales of Remoxy (6.0% to 11.5%).
The company had a collaboration agreement with Pfizer, Inc. (PFE - Free Report) for Remoxy, which was terminated by the latter in 2014.
The road to Remoxy’s development has been bumpy. It has already been issued Complete Response Letter (CRL) a few times. Most recently, in September 2016, the FDA issues a CRL, stating that Remoxy could not be approved in its present form, and specified additional actions and data is needed for drug approval. Pain Therapeutics resubmitted the Remoxy NDA in the first quarter of 2018
The abuse of opioid drugs is a serious problem in the United States, with companies like Endo Pharmaceuticals (ENDP - Free Report) having to withdraw its injectable formulation of Opana ER.
Pain Therapeutics currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank stocks here.
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