Alpharma Inc, a leading, global specialty pharmaceutical company, reported positive results from its phase III double-blind, randomised, placebo-controlled pivotal efficacy trial for its abuse-deterrent, extended-release opioid, ALO-01.
In the multi-centre trial of over 500 patients, ALO-01 demonstrated significant pain relief (p<0.05). This primary endpoint was agreed to by the FDA via the Special Protocol Assessment (SPA) process.
"These positive clinical results will support the NDA filing for ALO-01 we are targeting for the first half of 2008," commented Dean Mitchell, president and chief executive officer, Alpharma. "We believe that abuse deterrent products will play a significant role in the treatment of pain, and ALO-01 has the potential to be a breakthrough product."
"Data suggests that pain relievers have become the leading initial choice for first-time illicit drug users," said Nathaniel Katz, MD, MS Adjunct Assistant Professor of Anaesthesia at Tufts University School of Medicine. "Physicians are seeking pain treatment options that are effective, yet reduce legitimate concerns regarding potential abuse. Alpharma's proprietary technology combines an extended-release opioid with a sequestered core of the antagonist, naltrexone, in a single dosage form. If the product candidate is taken as directed, it is intended that the naltrexone will remain sequestered and the patient will achieve pain relief similar to morphine sulfate extended-release capsules. If the capsule is tampered with by crushing, chewing or dissolving, which are common approaches abusers use to accelerate euphoria, it is expected that the naltrexone will be released and euphoria will be significantly reduced."
"Alpharma's innovative approach to abuse deterrence holds significant promise for chronic pain patients and healthcare professionals as physicians may be more likely to choose ALO-01, if approved by the FDA, to treat moderate to severe pain than currently available opioid products which do not offer an abuse-deterrent mechanism," Dr. Katz added.
Alpharma Inc. is a global specialty pharmaceutical company with leadership positions in products for humans and animals. Alpharma is presently active in more than 60 countries. Alpharma has a growing branded pharmaceutical franchise in the US pain market with its Kadian (morphine sulfate extended-release) Capsules, and an innovative pharmaceutical product pipeline that consists of several novel approaches to treat pain, including the Flector Patch (diclofenac epolamine topical patch), which is expected to launch in early 2008.