Date: 2011-12-19
Type of information: Granting of a patent
Product name: Beprana®
Compound: naproxcinod
Therapeutic area: Inflammatory diseases
Action mechanism: This non-steroidal anti-inflammatory drug (NSAID) is a derivative of naproxen with a nitroxybutyl ester to allow it to also act as a nitric oxide (NO) donor. This second mechanism of action makes naproxcinod the first in a new class of drugs, the cyclooxygenase inhibiting nitric oxide donators (CINODs), that are hoped to produce similar analgesic efficacy to traditional NSAIDs, but with less gastrointestinal and cardiovascular side effects.
Company: Nicox (France)
Disease: relief of the signs and symptoms of osteoarthritis of the knee and hip in adults
Latest news: * On April 20, 2011, The European Medicines Agency announced that it has been formally notified by NicOx S.A. of its decision to withdraw its application for a centralised marketing authorisation for the medicine Beprana® (naproxcinod), 375 mg hard capsules. Beprana was intended to be used for the relief of the signs and symptoms of osteoarthritis of the knee and hip in adults.
Patents:
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE: 2011-04-20
US authorization:
UE authorization:
Favourable opinion UE:
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE: OTC status: Other news:
