Javelin Pharmaceuticals, Inc., a leading developer of novel products for pain control, has signed a Commercial Supply Agreement with Precision Pharma Services, Inc.

Under the agreement, Precision will manufacture vials of Javelin's injectable Dyloject product (diclofenac sodium 75mg / 2mL) for use in Javelin's anticipated European markets pending regulatory approval. The agreement has a two-year, renewable term and sets forth minimum purchase and production requirements, a Javelin Pharma press release stated.

"This agreement is an important step forward in growing Javelin's manufacturing infrastructure in anticipation of initial product sales later this year in Europe," said Michael Moshman, Javelin's Vice President for Clinical and Commercial Manufacturing. "Working with Precision Pharma will enable us to marshal the resources to meet future demand for Dyloject as we begin commercialising this promising analgesic with its launch in the UK in 2007."

Dyloject - injectable diclofenac sodium - is presently under review for marketing approval in the UK for the treatment of acute moderate-to-severe pain. Subsequent approval in other European countries is anticipated through a regulatory strategy following the Mutual Recognition Process. In the US, Dyloject is in Phase 3 clinical trials for the same indication. Earlier studies demonstrated Dyloject to be safe and well tolerated (including evidence for a lower incidence and severity of vein irritation than Voltarol, the currently marketed European formulation of injectable diclofenac). Prior studies have shown Dyloject to have a more rapid onset of action than Voltarol when both drugs were evaluated in patients with moderate-to-severe postoperative pain, and a more rapid onset of action than ketorolac in the molar extraction model of postsurgical pain. The latter study also indicated that Dyloject had half the incidence of surgical site bleeding compared with ketorolac.