Inmedix holds the “use” patent on pramipexole and seeks a partner to develop and market pramipexole on a worldwide basis for the treatment of Fibromyalgia.

Pramipexole is a second generation dopamine agonist and one of two discovered dopamine 2/3 receptor agonists commonly used to treat Parkinson’s disease and Restless Legs Syndrome. It has modest affinity for alpha-1 receptors (affecting autonomic arousal) and no effect on beta-adrenergic, serotonin, norepinepherine, muscarinic, opioid, GABA, dopamine (1,4,5), benzodiazepine or other CNS receptors. Because of its uniquely specific mechanism of action, important conclusions can be draw from observation of its clinical effect in patients with fibromyalgia.

Pramipexole was developed by Boehringer-Ingelheim and FDA approved for treatment of Parkinson’s disease in 1997.

Extensive published reports of clinical trials with pramipexole indicate that it is safe and well tolerated even in a high-risk elderly population with Parkinson’s disease. In the Inmedix Phase II FMS trial, the primary adverse events were weight loss
and transient, mild nausea.

Non-confidential Product Sheet for Pramipexole

Phase II Completed

The efficacy and safety of pramipexole as a treatment for Fibromyalgia was assessed in a randomized, double blind, dose
escalated, placebo-controlled trial which was published in Arthritis and Rheumatism in August 2005.

Pramipexole demonstrated the highest response rate of any FMS Phase II trail performed to date.

Phase II results as published in Arthritis and Rheumatism

Inmedix FMS use patent related to pramipexole US Patent Office number: US 6,300,365 B1