General Information

Jalyn is a single-capsule combination of dutasteride (0.5 mg) and tamsulosin (0.4 mg) Dutasteride inhibits the conversion of testosterone to dihydrotestosterone (DHT), the androgen primarily responsible for the initial development and subsequent enlargement of the prostate gland. Tamsulosin is an alpha-blocker and works by relaxing the muscles in the bladder and prostate.

Jalyn capsules are specifically indicated for the treatment of symptomatic benign prostatic hyperplasia in men with an enlarged prostate.

Clinical Results

FDA Approval
The FDA approval of Jalyn was based on two-year results from the CombAT (Combination of Avodart and Tamsulosin) study. This international multicenter, randomized, double-blind and parallel-group study enrolled 4,844 men with moderate-to-severe BPH symptoms. The subjects were randomized to receive dutasteride 0.5 mg/day plus tamsulosin 0.4 mg/day, dutasteride 0.5 mg/day or tamsulosin 0.4 mg/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. Over 24 months, Avodart and tamsulosin combination therapy provided a significantly greater improvement in symptoms from baseline than either Avodart or tamsulosin treatment alone (p < 0.001). In addition, Avodart resulted in continuous and sustained Qmax (urine flow rate) improvements to month 24. Treatment was well tolerated, with adverse events similar between all the treatment groups. Long-term (four-year) results showed that combined treatment with Avodart and tamsulosin significantly reduced the risk of acute urinary retention (AUR) or BPH-related surgery by 66% compared with tamsulosin alone (p<0.001). The combination therapy also significantly reduced the risk of BPH disease progression by 44% compared with tamsulosin and 31% compared with dutasteride alone. In addition, those treated with combination therapy reported a significant improvement in BPH symptoms at 4 years, as measured by the International Prostate Symptom Score (IPSS), with a mean change from baseline of -6.3 points, compared to -3.8 for tamsulosin and -5.3 for dutasteride alone.

Mechanism of Action

Jalyn is a single-capsule combination of dutasteride (0.5 mg) and tamsulosin (0.4 mg) Dutasteride is an FDA-approved drug for the treatment of symptomatic BPH in men with an enlarged prostate, to reduce the risk of acute urinary retention, and to reduce the risk of prostate-related surgery. Dutasteride inhibits the conversion of testosterone to dihydrotestosterone (DHT), the androgen primarily responsible for the initial development and subsequent enlargement of the prostate gland. 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.

Literature References

Montorsi F, Henkel T, Geboers A, Mirone V, Arrosagaray P, Morrill B, Black L Effect of dutasteride, tamsulosin and the combination on patient-reported quality of life and treatment satisfaction in men with moderate-to-severe benign prostatic hyperplasia: 4-year data from the CombAT study. International Journal of Clinical Practice 2010 May 7.

Barkin J, Roehrborn CG, Siami P, Haillot O, Morrill B, Black L, Montorsi F; CombAT Study Group Effect of dutasteride, tamsulosin and the combination on patient-reported quality of life and treatment satisfaction in men with moderate-to-severe benign prostatic hyperplasia: 2-year data from the CombAT trial. BJU International 2009 Apr;103(7):919-26

Roehrborn CG, Siami P, Barkin J, Damião R, Major-Walker K, Morrill B, Montorsi F; CombAT Study Group

The Journal of Urology