22 Jul 2013, BioSpectrum Bureau , BioSpectrum
Singapore: Australia-based QRxPharma has collaborated with Aesica Formulation Development for the world-wide promotion of QRxPharma's proprietary Stealth Beadlets Abuse Deterrence technology.
Aesica supplies pharmaceutical contract development and manufacturing services globally and operates six manufacturing sites across the UK, Germany and Italy. Aesica offers controlled drug services across the supply chain for which abuse or diversion may occur and is actively building relationships for supplying controlled drug Active Pharmaceutical Ingredients (APIs) and finished dose products to market.
"We are delighted to announce our collaboration with Aesica," said Dr John Holaday, MD and CEO, QRxPharma. "Their extensive experience in formulation development and contract manufacturing, together with their established client base in the controlled drug market, create a wonderful opportunity for our companies to collaborate in the application of our proprietary abuse deterrence technology by third party pharma companies."
Under the non-exclusive collaboration agreement, Aesica will promote QRxPharma's Stealth Beadlets technology for inclusion in their clients' existing formulations of controlled drugs. Aesica will enter into fee-for-service contracts with such third parties for the development of the new Abuse Deterrent Formulations (ADF) of specific drugs of interest, whilst QRxPharma will negotiate license terms directly with each party.
QRxPharma's Stealth Beadlets abuse deterrence technology was developed for the MoxDuo CR (controlled release) formulation for the treatment of chronic pain. This program is ready for Phase 2 studies and has shown that Stealth Beadlets incorporated into the Company's delayed release technology provide a potential once to twice-a-day formulation. Work is underway to assure that this ADF technology comports with United States Food and Drug Administration (FDA) guidelines for providing abuse deterrence statements in product labeling.
"A head-to-head comparison between Stealth Beadlets and a market leading abuse deterrent technology showed that Stealth Beadlets were more than twice as effective in reducing the percentage of oxycodone that could be extracted from a crushed controlled release tablet," said Dr. Holaday.
Stealth Beadlets may be incorporated into almost any potentially abused drug (e.g. opioids, amphetamines, sedatives, etc.) that are sold in solid dosage forms (e.g. tablet, capsule, sachet); they provide significant resistance against the extraction of active ingredients if crushed, solubilized or heated. Stealth Beadlets have no effect on the active ingredient release profile and consist entirely of patient-safe, low cost, excipients that have GRAS (Generally Regarded As Safe) status with the FDA. Patent applications for the ADF technology are currently under review at the U.S. patent office, and, if granted, will provide for product exclusivity until 2029.