The ORADUR® Sustained Release Gel Cap 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 gelatin 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® gel-cap 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. Pfizer is working to evaluate the issues described in the Complete Response Letter and plans to have further discussions with FDA around them.

The FDA's Complete Response Letter raised concerns related to, among other matters, the Chemistry, Manufacturing and Controls section of the NDA for REMOXY. In the opinion of Pain Therapeutics, potential regulatory approval of REMOXY in the U.S. is unlikely to occur in less than one year, and could be delayed significantly longer than a year.

Since 2006, we have also worked with Pain Therapeutics and King on the development of additional ORADUR abuse-resistant opioid drug candidates. Phase I clinical trials have been conducted for two of these ORADUR-based products (hydrocodone and hydromorphone), and an IND has been accepted by the FDA for the third ORADUR-based opioid (oxymorphone). The active ingredients in these two drug candidates are opioids whose identities have not been publicly disclosed.

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. We commenced Phase I studies in July 2010 with this program.

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