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news.US-based Collegium Pharmaceutical has announced that it has identified candidates for its Hydrocodone DETERx development program.
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The company is currently carrying out in-vitro testing on these candidates using a robust screening process developed during testing of more advanced products that incorporate the DETERx technology platform.
DETERx is a new, patent-protected drug delivery technology that is designed to maintain the extended-release (ER) and safety profiles of highly abused drugs following several methods of abuse and tampering employed by drug abusers such as crushing, chewing, snorting, and IV injection.
Three opioids have already been tested in the DETERx platform and have showed superior abuse-deterrent performance versus the marketed reference products.
Two of the company’s lead candidates, Oxycodone DETERx and Oxymorphone DETERx, have been granted Fast Track designation by the US FDA.
Currently, there is no abuse-deterrent formulation of hydrocodone on the market.
Following the advice of the FDA and Department of Health & Human Services, in February 2014, the US Drug Enforcement Administration (DEA) published a proposal to move hydrocodone combination products (HCPs) from Schedule III to Schedule II.
Rescheduling HCPs, a drug class with about 130 million prescriptions in 2013, will move HCPs to the same scheduling as OxyContin and other ER opioids.
Collegium CEO Michael Heffernan said the company expects Hydrocodone DETERx to provide similar advantages and unique product characteristics as its lead analgesic in development, Oxycodone DETERx.
"These features include abuse-deterrent properties that may decrease oral abuse (e.g., crushing, breaking, grinding), intranasal abuse, and abuse by injection. In addition, the microsphere-in-capsule, oral formulation may be sprinkled directly into the mouth, sprinkled onto soft foods, or delivered via feeding tubes," Heffernan said.
"These alternative dosing options have the potential to fulfil a critical unmet medical need for individuals with aversion to, inability, or difficulty swallowing intact tablets, including patients with chronic pain with dysphagia (CPD), who currently have limited options for pain control."