Danish Drug Company Egalet Aims to Make Abuse-Deterrent Hydrocodone
News about a joint collaboration with Japanese company, Shinogi, follows the FDA's controversial decision to approve the deterrent-less Zohydro.
Egalet Ltd., a Danish biotech company that produces pharmaceuticals, has recently entered into an agreement with Japan-based pharmaceutical company Shionogi to create and market a new formulation of pure hydrocodone that includes an abuse deterrent.
Current hydrocodone medications combine the opioid with drugs such as acetaminophen, NSAIDs, or antihistamines. Egalet’s proprietary tamper proof formula makes the hydrocodone pills very difficult to crush or dissolve, and adds a controlled-release component so that the pill cannot dissolve all at once in the gastrointestinal tract. Since many substance abusers’ main methods of administration involve crushing, grinding, or melting pills, this type of abuse deterrent aims to reduce misuse of the drug.
Egalet’s deal with Shinogi is valued at $425 million. Under the deal, Shinogi will fund the development of all the hydrocodone products and will have exclusive rights to commercialize the products globally. Bob Radie, president and CEO of Egalet, feels that the collaboration with Shinogi “provides validation for our proprietary abuse-deterrent drug delivery platform and positions us to capitalize on our technology, both through the products to be developed under the collaboration and by enabling us to develop additional opioid candidates utilizing our platform technology.”
Interestingly, this announcement comes on the heels of the FDA approving the new pure hydrocodone drug, Zohydro, despite its own advisory panel’s recommendation to wait until an abuse deterrent formula is available. While the manufacturers of Zohydro have stated that they are currently working on a tamper proof version of their drug, they have also noted that the process could take 1-3 years.
Prescription opioid painkillers have come under intense scrutiny lately as the level of overdose deaths has skyrocketed in recent years. Although creating abuse deterrent formulations seems like an obvious solution, it is not clear that it has been effective in decreasing the abuse of these drugs.