Pain Therapeutics (PTIE) Announces Receipt of FDA Complete Response Letter for REMOXY ER (DRRX)

September 26, 2016 7:02 AM EDT
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Pain Therapeutics, Inc. (Nasdaq: PTIE) announced today that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) on the resubmission of its new drug application (NDA) for REMOXY ER (oxycodone capsules CII). The CRL informs that REMOXY ER cannot be approved in its present form and specifies additional actions and data that are needed for drug approval.

The CRL focuses on the abuse-deterrent properties of REMOXY ER and proposed drug labeling. The CRL makes no mention of clinical safety, drug efficacy, manufacturing, stability, bioequivalence or any other issues from a prior Complete Response Letter.

Pain Therapeutics is evaluating the CRL and plan further discussions with the FDA. The CRL specifies additional actions that are needed in order to obtain approval of REMOXY ER with label claims against three routes of abuse (i.e., injection, inhalation and snorting). These actions may take approximately a year to conduct and may cost approximately $5MM, pending discussions with the FDA and outside clinical/regulatory consultants.

Conference CallPain Therapeutics will host a conference call on Monday, September 26th at 9:00am Eastern time to discuss the Complete Response Letter. To participate in this conference call please dial toll-free 1-877-407-4018 (U.S.) or 1-201-689-8471 (international).

Those interested in listening to the conference call live via the internet may do so by visiting www.paintrials.com. About two hours following the live call, a replay of the conference call will be available by phone through October 3, 2016. To listen to a replay of the call, please dial toll-free 1-877-870-5176 (U.S.) or 1-858-384-5517 (international) and press pin number 1212590.

Details of the Complete Response Letter (CRL)The CRL focuses on the actions and studies that are needed in order to obtain approval of REMOXY ER with label claims on three routes of abuse (i.e., injection, inhalation and snorting). In conducting the following studies, we will generally compare REMOXY ER vs. one or more commercially available oxycodone ER drug product:

  • To support a potential drug label claim against abuse by injection: Repeat an injectability/syringeability study using thin films of drug, smaller volumes of solvents, additional mixed solvents and alternative extraction methods and syringe filter.
  • To support a potential drug label claim against abuse by inhalation: Repeat a volatilization study using the same thickness for each drug to increase surface area.
  • To support a potential drug label claim against abuse by snorting: Conduct an intranasal abuse potential study in human volunteers (i.e., not the animal data we had submitted) with drug applied directly inside the human nasal cavity.

In addition, we had proposed in the REMOXY NDA a label claim against abuse by chewing. Our proposal was based on clinical results of an oral human abuse potential study that met all four co-primary endpoints with statistical significance and that also met several, but not all, secondary endpoints. The CRL asks us to submit a revised proposed label to indicate results of this study do not support a label claim against abuse by chewing.



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