Making prescription painkillers harder to abuse is the goal of a specialty pharmaceutical company that’s just secured $22.5 million to complete late-stage trials and seek regulatory approval for its tamper-resistant drug technology.
Collegium Pharmaceuticals’ leading candidate, COL-003, is a version of the popular opiate oxycodone in the company’s DETERx formulation — made into a capsule filled with small beads that contain a solid dispersion of the drug in an extended-release matrix. It’s designed so that the oxycodone isn’t released from within the beads until they hit certain enzymes and bile acids in the stomach.
According to the company, formulating the drug this way allows it to retain its time-release mechanism even after common methods of tampering, like crushing, chewing or heating, which allows users to get a quick high from current forms of extended-release narcotics and puts them at risk for dangerous overdoses.
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With the series B funding, Collegium will begin a phase 3 clinical study in patients with lower back pain. CEO Michael Heffernan told VentureWire he plans to file a new drug application (NDA) in 2013. COL-003 and COL-172, a similar formulation of oxymorphone, were granted fast-track designation by the U.S. Food and Drug Administration.
Sales of OxyContin topped $3 billion in 2009, creating a potentially huge market for Collegium. And the idea of making narcotics tamper resistant has been on the radar of regulatory agencies, foundations and drug companies for years. According to the Drug Abuse and Warning Network, abuse of oxycodone alone resulted in more than 100,000 trips to the ER in 2008.
What sets Collegium apart from other approaches to tamper-resistant formulations, the company says, is that its solution doesn’t use any antagonist or aversive agents in the drug.
In 2010, drugmaker Purdue Pharma L.P. released an OxyContin reformulation that was harder to crush and contained time-release properties that were dispersed throughout the pill. But almost immediately, blogs and message boards detailing ways to outsmart the pills appeared.
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Endo Pharmaceuticals and Pfizer have taken similar approaches with their pain drugs, and Pain Therapeutics is testing a version of oxycodone called Remoxy that makes the drug into a gummy texture that’s hard to inject or snort. California startup PharmacoFore is also working on an abuse-resistant formulation that functions similar to Collegium’s, but it appears to still be several years away from commercialization.
Collegium says its formulation could also be useful for patients who have trouble swallowing pills; the capsule can be opened and the beads poured over food or down a feeding tube.
Longitude Capital and Skyline Ventures led Collegium’s latest round, which also saw contributions from previous investors Frazier Healthcare Ventures and Boston Millennia Partners.
