Combined Treatment

Hanmi Pharmaceutical’s “Gugutams,” a combined treatment for prostatic hypertrophy and erectile dysfunction, received sales approval from the Korean Ministry of Food and Drug Safety.
Hanmi Pharmaceutical’s “Gugutams,” a combined treatment for prostatic hypertrophy and erectile dysfunction, received sales approval from the Korean Ministry of Food and Drug Safety.

 

Hanmi Pharmaceutical announced on October 21 that its “Gugutams,” a combined treatment for prostatic hypertrophy and erectile dysfunction, received sales approval from the South Korean Ministry of Food and Drug Safety. The combined drug contains 0.4 mg of tamsulosin and 5 mg of tadalafil.

As a prescription-based medicine, the capsule should be taken once a day after a meal. Hanmi Pharmaceutical said that it is the world’s first treatment combining the two drug ingredients.

The tadalafil-tamsulosin combined treatment proved its safety and efficacy through the phase 3 clinical trials carried out in 15 university hospitals in Korea. The phase 3 clinical trials conducted on 492 male patients, who suffer from both prostatic hypertrophy and erectile dysfunction, after dividing into three groups – one taking a single 5 mg dose of tadalafil, one taking 0.2 mg of tamsulosin and 5 mg of tadalafil and one taking 0.4 mg of tamsulosin and 5 mg of tadalafil.

After 12 weeks of the study, the group taking 0.4 mg of tamsulosin and 5 mg of tadalafil saw the International Prostate Symptom Score (IPSS) decrease by 28 percent than the one taking a single 5 mg dose of tadalafil, but showed the same International Index of Erectile Function (IIEF) score. However, the medicine didn’t show any statistical significance compared to the group taking 0.2 mg of tamsulosin.

The findings of the phase 3 clinical trials won the best subject award in the clinical trial sector at the International Society for Sexual Medicine (ISSM) held in last September. The ISSM is the world’s largest meeting in male sexual medicine areas, participated in by 1,000 urologists. 

Park Myung -hee, a marketing executive at Hanmi Pharmaceutical, said, “The current data shows that 8.5 out of 10 patients who have erectile dysfunction in Korea also suffer from prostatic diseases. Tamsulosin, one of the ingredients in our new drug, is said to have less side effects related with the cardiovascular systems than other ingredients that treat prostatic hypertrophy.”

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