FDA approves Jalyn medication for enlarged prostate symptoms

The U.S. Food and Drug Administration (FDA) has approved Jalyn, a single-capsule combination of dutasteride (0.5 mg) and tamsulosin (0.4 mg), for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate. BPH is a common prostate disorder affecting approximately half of men aged 50 and older in the U.S. Jalyn offers a dual mechanism of action in one capsule to improve symptoms and reduce prostate size over time.

GSK expects the product to be available in the second half of 2010. The approval was based on two-year data from the CombAT (Combination of Avodart and Tamsulosin) study, one of the largest clinical trials to date involving nearly 5,000 men. The study demonstrated that co-administration of dutasteride and tamsulosin significantly improved BPH symptoms compared to either medication alone.

Common symptoms of BPH include waking at night to urinate, frequent urination, urgency, incomplete bladder emptying, intermittent stream, and a weak stream. If left untreated, severe BPH can lead to serious complications such as acute urinary retention or the need for surgery.