Key Developments For Pain Therapeutics Inc
Pain Therapeutics Inc (PTIE.O) (Consolidated Issue listed on NASDAQ Global Market)
King Pharmaceuticals, Inc. And Pain Therapeutics, Inc. Announce REMOXY NDA Update
King Pharmaceuticals, Inc. and Pain Therapeutics, Inc. announced that on July 2, 2009, King met with the US Food and Drug Administration (FDA) to discuss the Complete Response Letter regarding the New Drug Application (NDA) for REMOXY. The outcome of this meeting provided King with a clear path forward to resubmit the REMOXY NDA and to address all FDA comments in the Complete Response Letter. King now anticipates the resubmission of the NDA could occur mid-year 2010. King believes the rate-limiting step is the generation of six-month stability data, and no new clinical trials are required. King remains committed to the development and commercialization of REMOXY, and looks forward to working closely with the FDA toward approval of the product.
Pain Therapeutics, Inc. Initiates Clinical Study In Cancer Patients
Pain Therapeutics, Inc. announced the initiation of another clinical study for PTI-188, an investigational drug intended to treat a lethal form of skin cancer called metastatic melanoma (MM). This study follows the release of promising data in an earlier Phase I study for PTI-188.
Pain Therapeutics, Inc. Receives Complete Response Letter From FDA For REMOXY
Pain Therapeutics, Inc. announced that it has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for REMOXY, an abuse-resistant controlled-release form of oxycodone. Based on its review, the FDA has determined that the NDA is not approved in its present form. The FDA believes additional non-clinical data will be required to support the approval of REMOXY. The FDA has not requested or recommended additional clinical efficacy studies prior to approval.
US FDA Questions King Pharmaceuticals, Inc. And Pain Therapeutics Data-Reuters
Reuters reported that U.S. drug reviewers could not determine the tamper-resistance properties of an experimental painkiller developed by King Pharmaceuticals and Pain Therapeutics. Pain Therapeutics tested the extraction of oxycodone from Remoxy when exposed to solvents for up to an hour but did not look beyond one hour, Food and Drug Administration said. In the absence of this information, it is not possible to make conclusions regarding the tamper-resistant properties of the formulation. The companies are jointly developing the drug.
DURECT Corporation Announces IND Submission By Pain Therapeutics, Inc. For Third Abuse Resistant Opioid Pain Medication Based On ORADUR Technology
DURECT Corporation announced that Pain Therapeutics, its licensee, has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for an abuse-resistant opioid pain drug candidate based on DURECT's patented ORADUR technology. This ORADUR-based opioid drug candidate covered by DURECT's collaboration with Pain Therapeutics, for which King Pharmaceuticals holds the commercialization rights. Pain Therapeutics and King Pharmaceuticals have stated that they expect to announce shortly the initiation of a clinical study with this new investigational drug candidate.
