FDA Approves Stronger Dose of Exalgo

FDA Approves Stronger Dose of Exalgo

The Food and Drug Administration has approved a stronger 32 mg dose of Exalgo, an opioid painkiller used to treat patients with moderate to severe chronic pain who need continuous, around-the-clock analgesia.

Extended release 32 mg tablets will be available in the next few weeks, according to Mallinckrodt, the drug’s manufacturer. Until now, only weaker doses of Exalgo have been available in 8, 12 and 16 mg tablets.

FDA approval of the stronger dose is significant for Mallinckrodt, the pharmaceuticals branch of Covidien (NYSE: COV), because Exalgo showed greater effectiveness at higher doses during clinical trials.

“This new EXALGO 32 mg tablet represents an important milestone as 32 mg was the median effective dose upon which patients were stabilized during the pivotal trial,” said Thomas Smith, MD, Chief Medical Officer of Mallinckrodt. “By providing a variety of tablet strengths, we hope that physicians and opioid-tolerant patients can work together to develop and tailor a treatment regimen that adequately and appropriately controls their chronic pain.”

Exalgo is formulated to provide a steady release of hydromorphone throughout the day. That minimizes the “peaks and valleys” experienced by chronic pain patients who rely on immediate-release products that require more frequent doses.

“Physicians may try as many as five types of opioids before finding a treatment plan that provides pain relief to patients,” said Joseph Shurman, MD, chairman of Pain Management at Scripps Memorial Hospital. “Sustained release treatments like Exalgo help patients avoid fluctuations in blood plasma levels and a new tablet strength provides more options for physicians to use with their opioid-tolerant patients.”

Exalgo has physical properties that make it more difficult to crush or dissolve, which drug abusers often do with painkillers so they can snort or inject the active ingredient.

The rights to Exalgo were acquired in 2009 from Zalicus Inc. (NASDAQ: ZLCS), a Massachusetts biopharmaceutical company that develops new drugs for patients suffering from pain and inflammatory diseases. Zalicus continues to receive royalties on sales of Exalgo from Mallinckrodt.

Authored by: Pat Anson, Editor