FDANews

MHRA Considers Widening Availability of Naproxen

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has issued a public consultation on whether naproxen 250-mg tablets should be made available OTC for treating primary dysmenorrhoea, or period pain, for women ages 15 to 50. Drugs containing naproxen are currently available only by prescription in the UK.

If naproxen becomes available in pharmacies, it would be an alternative to ibuprofen, which is currently the only nonsteroidal anti-inflammatory drug available OTC for the treatment of primary dysmenorrhoea.

The MHRA said this proposal is in line with its initiative to widen availability of medicines for women's health. The MHRA added it supports switching drugs to OTC status where it is safe to do so. The agency is also considering the reclassification of Cyklo-f (tranexamic acid) for the OTC treatment of heavy menstrual bleeding.

Naproxen has been available in the UK for more than 30 years as a prescription medicine for the treatment of rheumatic disease and other musculoskeletal disorders, dysmenorrhoea and acute gout.