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Extended-release, abuse-deterrent opioid safe, effective for chronic low back pain

Egalet Corporation recently announced that Egalet-002, an extended-release, abuse-deterrent form of oxycodone, demonstrated safety and efficacy endpoints for the treatment of moderate-to-severe chronic low back pain in a phase 3 trial.

The multicenter, double-blind, enriched enrollment, randomized withdrawal study evaluated how safe and effective Egalet-002 was in opioid-experienced and opioid-naïve patients with moderate-to-severe chronic low back pain compared with placebo.

The results showed that average pain intensity from randomization to week 16 was statistically and significantly different among patients with receiving Egalet-002 vs. placebo.

In a previous safety study of Egalet-002, the drug was found to be generally well-tolerated for up to 56 weeks in opioid-experienced patients with moderate-to-severe chronic noncancer pain.

The current study did not identify any new safety concerns.

“These results demonstrate Egalet-002, an abuse-deterrent, extended-release oxycodone, provided effective pain relief for patients with moderate-to-severe chronic back pain,” Bob Radie, president and CEO of Egalet, said in a press release. “Given the prevalence of chronic back pain combined with the prescription abuse epidemic, we believe development of more abuse-deterrent products like Egalet-002 is important for our communities.”

Disclosure: Healio Internal Medicine was unable to confirm relevant financial disclosures at the time of publication.