Pain Therapeutics won two grants worth a total of $4 million from the NIH to support the development of a blood-based diagnostic for Alzheimer’s disease and its fentanyl-based Fenrock™ transdermal patch for treating severe pain.
The funding includes a $1.8 million research grant from the National Institute on Aging (NIA), to fund the development of a blood test for Alzheimer’s disease, based on Pain Therapeutics’ clinical-stage PTI-125 drug candidate for Alzheimer’s disease. PTI-125 is an oral, small-molecule drug that was designed in-house, for which an NDA application to start clinical studies was cleared in July. A first-in-human clinical study with PTI-125 will be funded by a $1.7 million NIH grant, which was awarded in June. Results from the study are expected by the end of 2017.
Commenting on the NIA grant to support development of the blood-based Alzheimer’s disease diagnostic, Remi Barbier, president and CEO of Pain Therapeutics, stated, “A blood test may help detect Alzheimer’s disease before symptoms occur, or rule out other possible causes of memory problems, or might be used as a biomarker to measure the efficacy of drug candidates during clinical trials.”
Pain Therapeutics separately has been awarded a R&D grant worth approximately $2.2 million from NIH’s National Institute on Drug Abuse (NIDA) to support development of its fentanyl-based abuse-deterrent Fenrock™ transdermal patch-based therapy for treating severe pain. “We are grateful for NIDA’s scientific and financial support for Fenrock,” Barbier noted. “This grant underscores the urgent need to better address the abuse potential of currently marketed fentanyl patches.”
Pain Therapeutics’ lead candidate Remoxy® ER is a proprietary, extended-release oral formulation of oxycodone. A second NDA for the drug was submitted by the company in March 2016. Remoxy ER had previously been licensed to Pfizer, and a prior NDA was met by an Complete Response Letter (CRL) from FDA in 2011, in which the FDA noted that additional actions would be required to address label claims for the injection-, inhalation-, and snorting-related abuse-deterrent properties of the drug. Pain Therapeutics met with the FDA in February, and an agreement was reached on the additional studies required. The firm said it expects to complete the studies by the end of 2017, at a cost of approximately $3 to $4 million, after which it will meet again with the FDA prior to resubmitting the NDA.