Wednesday, March 17, 2010

Alkermes launches Phase 1 trial for chronic pain drug candidate

By Julie M. Donnelly

Alkermes Inc. has launched an early stage drug trial for a potential treatment for side effects of opiod use for patients will chronic pain.

The Waltham-based company will conduct a Phase 1 study on ALKS 37, a drug target to treat constipation brought on by opiod use. The study will involve 24 patients and will assess the safety, tolerability and absorption of daily oral administration of two dose levels of ALKS 37 for a seven day period .

“ALKS 37, one of several proprietary product candidates in our growing clinical pipeline, is an excellent example of how the company is leveraging its unique understanding of opioid biology and pharmacology to develop medications with potential advantages over currently available therapies,” said Dr. Elliot Ehrich, Chief Medical Officer of Alkermes, in a statement.

A previous single dose clinical study in healthy volunteers, which showed that ALKS 37 was generally well tolerated. The company expects to finish this second phase 1 study and begin the Phase 2 study in the first half of calendar 2010.

According to IMS Health, over 200 million prescriptions were written for opioids in 2007 in the United States.