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Wednesday, August 12, 2009

Javelin’s pain reliever study falls short of expectations

By Mass High Tech staff

Javelin Pharmaceuticals Inc., a Cambridge pain management product developer, reported results of a Phase 3 study of Ereska, a nonopioid pain reliever intended for intranasal delivery, that failed to meet the company goals outlined for the study.

The study tested 259 patients, with random distribution of either a placebo or Ereska, in repeated doses following orthopedic surgery. Javelin officials noted “typically mild and transient” psychological side effects in 3 percent or less of the subjects taking Ereska. The official results turned up a pain intensity difference between Ereska and the placebo that fell slightly short of clinical standards.

Ereska uses ketamine as its active ingredient. At high doses, ketamine has been used as a general anesthesia, the company reports. As a street drug known as Special “K”, ketamine is reported by the U.S. Drug Enforcement Agency to have potential consequences of “delirium, amnesia, depression, and long-term memory and cognitive difficulties.” Javelin (AMEX: JAV) uses ketamine in small doses to develop its Ereska drug as a single-use analgesic, or in pain-relieving combination with opioids.

Last November, Javelin cut staff levels by 15 percent in an effort to lower company costs.



 

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