BDSI, Evonik Partner To Develop Pain Management, Opioid Dependence Injectable
By C. Rajan, contributing writer
BioDelivery Sciences International (BDSI) and Evonik Corporation have entered into an exclusive agreement for the development and commercialization of a new long acting microparticle formulation of buprenorphine, which can provide up to 30 days of continuous pain therapy with a single injection.
German specialty chemicals giant Evonik will hold the exclusive rights to develop the formulation and manufacture the product(s). Evonik said that the buprenorphine formulation will be developed using the company’s proprietary microparticle technology and biomaterials and will be manufactured at its Alabama plant.
Under the terms of the deal, BDSI will have the right to license the product(s) once the Phase 1 ready formulations are prepared by Evonik, after which Evonik will be eligible for milestone payments from BDSI following regulatory filings and NDA approvals, as well as product royalties.
BDSI will develop the product for the indication of opioid dependence initially. BDSI has also obtained the rights to develop a future product for the treatment of chronic pain in patients and has secured the options to license the intellectual property for these products from Evonik.
BDSI aims to finish the development work and have the product ready for clinical trials by late 2015, with the goal of submitting an NDA within the next three years.
"The potential availability of a long-acting formulation of buprenorphine has the opportunity to significantly advance the treatment of opioid dependence and furthers our commitment to this underserved treatment area," said Dr. Mark A. Sirgo, President and CEO of BDSI.
"Not only would a single monthly injection provide an opportunity to substantially improve adherence to buprenorphine treatment, which is a formidable problem for many patients, it could also help to eliminate the problem of diversion. We also believe this will be an outstanding companion product to Bunavail and, if approved, provides another product for our existing sales team."
North Carolina based BDSI also just announced today that it has launched its new pain medication Bunavail in the U.S, along with its commercialization partner Quintiles. Bunavail (buprenorphine and naloxone) is the only FDA-approved formulation of pain medication that can be administered inside the cheek, which makes it easier for patients to continue with their normal activities while receiving consistent doses of the medication.
According to BDSI, an estimated 2.5 million Americans are dependent on prescription opioids or heroin, and patient adherence makes it difficult to manage opioid dependence for long term treatments.