|From: alacirb (Rep: 6)||Date: 12/16/2009 15:39|
|Forum: Javelin Pharmaceuticals - Msg #59||Thread #672855867 (Rec: 0) |
Javelin Pharmaceuticals Inc. on Wednesday submitted for review its drug target for pain management to the U.S. Food and Drug Administration.
The Cambridge, Mass.-based biotechnology company’s product, Dyloject, is a non-steroidal, anti-inflammatory drug target for the management of pain in adults.
“Our NDA (new drug application) submission for Dyloject is a significant milestone for Javelin. It reflects our commitment to patients suffering from acute moderate-to-severe pain, whose need ... in both the inpatient and day surgery settings is currently underserved,” stated Martin J. Driscoll, CEO of Javelin Pharmaceuticals Inc., in a prepared statement.
Javelin’s submission includes 16 clinical studies including two phase 3 studies involving more than 1,300 U.S. patients. Patient populations included the elderly (65 years of age and older) and patients with mild-to-moderate renal or mild hepatic insufficiency.
Diclofenac sodium, the active pharmaceutical ingredient in Dyloject is one of the most widely prescribed non-steroidal, inti inflammatory drug. It is approved and marketed in a variety of forms in the United States including several oral formulations, a topical gel as well as patch and ophthalmic drops. However, an injectable formulation is not yet available in the United States.
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