Neuromed Concludes a Special Protocol Assessment (SPA) with FDA for a Pivotal Phase 3 Study on... (ame DILAUDID(R) and is also available fr...)

Neuromed Concludes a Special Protocol Assessment (SPA) with FDA for a Pivotal Phase 3 Study on NMED-1077

Date:10/15/2007

ame DILAUDID(R) and is also available from various generic manufacturers. Current formulations of hydromorphone marketed in the U.S. are immediate release, requiring dosing several times per day. NMED-1077 employs the OROS(R) PUSH-PULL(TM) osmotic delivery system to release hydromorphone at a controlled rate over an extended period. OROS(R) Hydromorphone has been approved in Germany and other European countries and is marketed by Janssen-Cilag under the name JURNISTA(TM).

NMED-1077 is an investigational product and is not approved by the FDA for use in the U.S. NMED-1077 has been studied in more than 1,000 patients in analgesic trials. The most common adverse events seen in clinical trials to date are opioid-related events such as constipation, nausea, somnolence, headache, vomiting and dizziness. Respiratory depression is the most important hazard of opioid preparations including NMED-1077.

Neuromed is also evaluating two pathways for the development of new classes of oral pain drugs. In collaboration with Merck, Neuromed is researching compounds designed to block the N-type calcium channel, a target linked to pain signal transmission. Separately, Neuromed is also developing T-type calcium channel blockers for the treatment of acute and chronic pain as well as other potential disorders such as hypertension and epilepsy.

About Neuromed

Neuromed is a privately held biopharmaceutical company in business to develop safer and more effective pain drugs. We are combining our pharmaceutical expertise in research, development and commercialization to improve existing pain treatments as well as develop new pain medicines. For more information visit http://www.neuromed.com.

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OROS(R) and PUSH-PULL(TM) are trademarks of ALZA Corporation; DILAUDID(R)

is a trademark of Abbott Laboratories.

Neuromed cautions you that statements included i
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