Regulators in the USA have given the green light to GlaxoSmithKline’s combination drug Jalyn to treat symptomatic benign prostatic hyperplasia in men with an enlarged prostate.

The US Food and Drug Administration has approved Jalyn, which is a single-capsule combination of GSK’s BPH drug Avodart (dutasteride) and tamsulosin, which is sold for BPH by Boehringer Ingelheim and Astellas Pharma under a variety of band names (eg Flomax, Alna, Harnal) and is available generically. The go-ahead was based on two-year results from a 4,844-patient study which showed that the combo improved urinary symptoms as opposed to either medicine alone.

Reported adverse events were consistent with the known safety profiles of dutasteride and tamsulosin, and the most common adverse reactions reported were impotence, decreased libido, breast and ejaculation disorders, as well as dizziness. GSK expects to make Jalyn available during the second half of 2010 in the USA, having received approval from regulators in Europe for the once-daily treatment in April, where it will be sold as Duodart.

Anne Phillips, R&D medicine development leader at GSK, noted that “this is the first time these therapies will be available together in a once-daily capsule”. She added that “Jalyn offers two mechanisms of action to provide symptom improvement and the ability to shrink the prostate over a sustained time”.

BPH affects 50% of men over 50 and over 90% of men older than 80.