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Javelin Pharmaceuticals, Inc. today announced that it has submitted its drug target for pain to the U.S. Food and Drug Administration for review.
The Cambridge-based biotechnology company’s product, Dyloject, is an IV non-steroidal anti-inflammatory drug (NSAID) target for the management of acute moderate-to-severe pain in adults. If the FDA approves it, it would be the first NSAID in the U.S. since ketorolac in 1990.
“Our NDA submission for Dyloject is a significant milestone for Javelin. It reflects our commitment to patients suffering from acute moderate-to-severe pain, whose need for effective and safe analgesia in both the inpatient and day surgery settings is currently underserved,” stated Martin J. Driscoll, CEO of Javelin Pharmaceuticals, Inc, in a 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 NSAIDs. It is approved and marketed in a variety of forms in the U.S. including several oral formulations, a topical gel, patch and ophthalmic drops. However, an injectable formulation is not yet available in the United States.
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