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FDA awards another non-opioid pain drug breakthrough status

Second drug fast-tracked amid addiction epidemic

FDA

The FDA is prioritising the approval of new non-opioid pain treatments, as part of the US battle against its opioid addiction epidemic.

The US regulator yesterday awarded Concentric Analgesics and its pipeline drug CA-008 in post-surgical pain with an FDA Breakthrough Therapy designation (BTD).

Concentric specialises in novel non-opioid pain therapeutics, and CA-008 is a first-in-class non-opioid therapeutic that rapidly converts to capsaicin, a potent TRPV1-agonist.

The company says CA-008 provides long-lasting pain relief after a single, local injection by selectively desensitising pain-conducting nerve fibres, without producing numbness or weakness.

Frank Bellizzi, CEO of Concentric Analgesics said the BTD confirmed the strong early data for the treatment, which is designed to treat pain and eliminate the need for opioids in the post-operative period.

The Breakthrough Therapy designation is based on phase Ib placebo-controlled clinical trial in patients undergoing bunionectomy. In this study, CA-008, at the highest dose, showed a 63% reduction of pain intensity when compared to placebo, and a nearly 50% reduction in opioid consumption in patients taking CA-008, compared to placebo.

The announcement follows a BTD in June for Heron Therapeutics and its HTX-011, also for post-operative pain management.

Other non-opioid treatments in the late-stage pipeline are Pfizer and Lilly’s tanezumab and Regeneron and Teva’s fasinumab.

The FDA has called the opioid epidemic “one of the most profound public health crises” facing the US, and is working with other US agencies on a range of measures to prevent more people becoming addicted to opioid painkillers after having been prescribed them by doctors. Many addicted people progress from prescription painkillers on to heroin, a deadly trend which contributed to deaths from drug overdose rise to 72,000 last year.

Studies suggest that that one in 10 patients in the US become addicted or dependent on opioids following surgery, adding to their prescription for patients with chronic pain conditions.

For this reason, the FDA is encouraging new alternatives and products, including an ‘innovation challenge’ to spur the development of medical devices, including diagnostic tests and digital health tech to help combat the crisis.

Meanwhile one company, Purdue Pharma, has become increasingly identified for fuelling the epidemic with its opioid products, especially OxyContin, a timed-release formulation of opioid pain medication oxycodone.

An in-depth investigation published this week by the Financial Times pharma correspondent David Crow How Purdue’s ‘one-two’ punch fuelled the market for opioids claims the company’s aggressive marketing played a major role in creating the epidemic of addiction.

Article by
Andrew McConaghie

12th September 2018

From: Marketing

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