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.
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. In October 2013, Pfizer stated that, having achieved technical milestones related to manufacturing, they will continue the development program for REMOXY®. Following guidance received from the FDA earlier this year, Pfizer announced that they will proceed with the additional clinical studies and other actions required to address the Complete Response Letter received in June 2011. These new clinical studies will include, in part, a pivotal bioequivalence study with the modified REMOXY formulation to bridge to the clinical data related to the original REMOXY formulation, and an abuse-potential study with the modified formulation. As previously disclosed, the complete response submission is not expected to occur prior to mid-2015. There can be no assurance that Pfizer 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). Under this agreement, the parties will collaborate to perform a clinical development program 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. In 2013, DURECT announced that we and Orient Pharma have selected a lead formulation for the lead program in DURECT ’s ORADUR-ADHD program, ORADUR-Methylphenidate. This lead formulation was chosen based on its potential for rapid onset of action, long duration with once-a-day dosing and target pharmacokinetic profile as demonstrated in a recent Phase 1 trial. In addition, this product candidate will utilize a small capsule size relative to the leading existing long acting products on the market and incorporates DURECT’s ORADUR anti-tampering technology. Orient Pharma is planning to meet with the Taiwan Food and Drug Administration (TFDA) later this year to discuss the Phase 3 program in that market and is developing its plans for further development in the defined Asian and South Pacific countries to which it has rights from DURECT. DURECT retains rights to all other markets in the world, notably including the U.S., Europe and Japan, and is initiating licensing discussions with other companies now that the lead formulation has been selected.
Download the ORADUR® Fact Sheet (.PDF)
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