GSK Bags FDA Approval For Jalyn Combination

GSK said that the FDA approval for the combination was based on the results from a two-year study CombAT (Combination of Avodart and Tamsulosin), an international multicenter, randomised, double-blind and parallel-group study.

In the study, men [aged =50 years with a prostate volume (PV) =30 cc, serum prostate-specific antigen (PSA) level 1.5-10ng/ml, Qmax >5 and =15ml/sec with a minimum voided volume =125ml and International Prostate Symptom Score (IPSS) =12] with moderate-to-severe BPH symptoms were randomised to receive dutasteride 0.5mg/day plus tamsulosin 0.4mg/day, dutasteride 0.5mg/day, or tamsulosin 0.4mg/day.

The study compared changes in urinary symptoms seen with dutasteride co-administered with tamsulosin as opposed to either medicine alone. Changes were measured via a validated symptom index.

Dutasteride, marketed by GSK as Avodart, currently is FDA-approved treatment of symptomatic BPH in men with an enlarged prostate, to reduce the risk of acute urinary retention (AUR), and to reduce the risk of prostate-related surgery.

Avodart treats symptoms and over time can shrink the prostate. Tamsulosin, an alpha-blocker, is indicated for the treatment of the signs and symptoms of BPH. Tamsulosin works by relaxing the muscles in the bladder and prostate.

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