Aesica Pharmaceuticals, the global contract development and manufacturing organisation (CDMO), has today announced the signing of an agreement between its subsidiary, Aesica Formulation Development Ltd, and QRxPharma Limited, for the global promotion of QRxPharma’s proprietary Stealth Beadlets® abuse deterrence technology.
Aesica supplies pharmaceutical contract development and manufacturing services internationally and operates six manufacturing sites across the UK, Germany and Italy. The company provides controlled drug services across the supply chain, for which abuse or diversion may occur, and is actively building relationships for supplying controlled drug APIs and finished dose products to market.
Under the non-exclusive Collaboration Agreement, Aesica will promote QRxPharma’s Stealth Beadlets technology for specific use in controlled drugs formulations. The company will enter into fee-for-service contracts with customers for the development of the new Abuse Deterrent Formulations (ADF) of specific drugs, whilst QRxPharma will negotiate license terms directly with the Aesica clients concerned.
QRxPharma’s proprietary Stealth Beadlets abuse deterrence technology was developed for the MOXDUO® CR (controlled release) formulation for the treatment of chronic pain. This programme is ready for Phase 2 studies and has already 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 fully conforms with FDA guidelines for the provision of abuse deterrence statements in product labelling.
Stealth Beadlets can 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. Moreover, 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 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 through to 2029.
Alan Raymond, Sales and Marketing Director at Aesica Pharmaceuticals commented: “Aesica is very pleased to have secured this contract with QRxPharma. Indeed, we are committed to providing our customers with the most advanced technologies available for best performance and, consequently, the provision of Stealth Beadlets abuse deterrence technology in formulation development is set to be a highly beneficial addition for our customers in the pharmaceutical and life science markets.”
He continued: “We look forward to making this innovative technology readily available to customers across our international network“.
Remarking on the collaboration, Dr. John Holaday, Managing Director and Chief Executive Officer at QRxPharma, said: “We are delighted to announce our collaboration with Aesica. Their extensive experience in formulation development and contract manufacturing, together with their established client base in the controlled drugs market, creates a wonderful opportunity for our companies to collaborate in the application of our proprietary abuse deterrence technology by third party pharma companies”.
He added: “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.”