The ORADUR® Sustained Release Technology
We are developing ORADUR® sustained release oral technology based on our SABER technology. We believe that ORADUR® can transform short-acting oral capsule dosage forms into sustained release oral products. Products based on our ORADUR® technology can take the form of an easy to swallow capsule that uses a high-viscosity base component such as sucrose acetate isobutyrate (SAIB) to provide controlled release of active ingredient for a period of 12 to 24 hours of drug delivery. Oral dosage forms based on the ORADUR® technology may also have the added benefit of being less prone to abuse (e.g., by crushing or alcohol or water extraction) than other controlled release dosage forms on the market today. ORADUR-based products can be manufactured by a simple process using conventional methods making them readily scalable. These properties have the potential to make ORADUR-based products an attractive option for pharmaceutical companies that seek to develop abuse deterrent oral products.
The ORADUR® Technology is the basis of Remoxy®, a novel long-acting oral formulation of the opioid oxycodone which is targeted to decrease the potential for oxycodone abuse. We have licensed worldwide rights to Remoxy® and three other ORADUR-based opioids to Pain Therapeutics, which has in turn licensed the commercialization rights to King Pharmaceuticals. As a result of Pfizer's acquisition of King in February 2011, Pfizer now has commercialization rights to Remoxy and the three other ORADUR-based opioids.
In June 2008 the NDA for Remoxy was filed with the FDA, and in December 2008, Pain Therapeutics received a Complete Response Letter in which the FDA determined that the NDA was not approved. According to Pain Therapeutics, the FDA indicated that additional non-clinical data will be required to support the approval of Remoxy, but the FDA has not requested or recommended additional clinical efficacy studies prior to approval. In March 2009, King Pharmaceuticals assumed responsibility for the Remoxy NDA from Pain Therapeutics. King resubmitted the NDA in December 2010. On June 23 2011, Pfizer received a Complete Response Letter from the FDA. The issues raised in the Complete Response Letter relate primarily to manufacturing. Pfizer has efforts underway to resolve these issues. On May 10, 2013, Pfizer disclosed that they had met with the FDA in March 2013 to discuss their plan to address the June 2011 Complete Response Letter. Pfizer stated that they had received written guidance from the FDA in May regarding required next steps, including additional clinical studies, to address the letter. Based on this guidance, Pfizer is considering their options with respect to Remoxy. If Pfizer elects to continue development of Remoxy, they would not expect to submit a response to the Complete Response Letter before mid-2015. We understand from Pfizer that additional clinical studies are necessary and include, in part, a pivotal bioequivalence study with the modified formulation to bridge to the clinical data conducted with the original formulation, as well as an abuse potential study with the modified Remoxy formulation. There can be no assurance that Pfizer will elect to continue development of Remoxy or that they will be able to resolve the concerns raised in the Complete Response Letter.
In August 2009, we signed a development and license agreement with Orient Pharma related to a drug candidate based on our ORADUR Technology and one specified active pharmaceutical ingredient for the treatment of attention deficit hyperactivity disorder (ADHD). This drug candidate is intended to provide once-a-day dosing with added tamper resistant characteristics to address common methods of abuse and misuse of these types of drugs. Under this agreement, the parties will collaborate to perform a clinical development program through a Phase II study intended to produce a data package that will support later stage development of the drug candidate and subsequent licensing by DURECT. We will be responsible for formulation and study design of the pre-defined clinical program, which Orient Pharma will fund and execute. Since 2010 we have conducted several Phase I clinical trials in this program with multiple formulations. Based on information from these trials, we are continuing to optimize the lead formulations and are planning next steps in our ORADUR-ADHD program.
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