Javelin Pharmaceuticals gets UK marketing approval for Dyloject
US-based Javelin Pharmaceuticals has received marketing authorization approval in the UK for a proprietary injectable formulation of Dyloject.
US-based Javelin Pharmaceuticals has received marketing authorization approval in the UK for a proprietary injectable formulation of Dyloject.
"Dyloject's UK approval is a milestone in establishing Javelin as a commercial provider of novel solutions for acute pain management," said Dr Daniel Carr, Javelin's ceo and cmo.
"Dyloject's high efficacy, ease of administration by rapid intravenous (IV bolus) injection, quick onset, long shelf-life, and favourable safety profile fulfill unmet medical needs while fitting perfectly with today's practice of acute pain control."
The Company's UK sales force is in place to promote Dyloject. Commercial launch of the product will occur upon finalisation of a National Health Service (NHS) list price and inclusion in local hospital formularies. The latter is needed to generate access to the product among key prescribers, including anesthesiologists. Dyloject pricing is not subject to NICE, the centralised UK reimbursement process.
Dyloject employs a proprietary solubilising agent that is significantly less irritating to veins than the organic solvents used in the currently marketed IV diclofenac formulation.
According to IMS Health, a well-known pharmaceutical market intelligence provider, the original formulation of diclofenac sodium is the most widely prescribed injectable NSAID in the UK and is sold in numerous countries throughout the world. I
Javelin's UK marketing authorization is the first step in securing distribution and positioning of Dyloject in the global market for pain medications including NSAIDs. Javelin intends to file additional marketing applications in a number of EU countries in coming months.