Zydus Cadila secures USFDA nod for schizophrenia drug

Cadila Healthcare Ltd of Zydus Cadila, on Wednesday said its specialty division Zydus Urosciences would soon be launching a next generation therapy for the treatment of erectile dysfunction (ED) for the first time in the country.
The product, Udenafil, a newly developed, potent and selective Phosphodiesterase 5 (PDE5) inhibitor approved for the treatment of ED, is being launched under the brand name ‘Udzire’. The Zydus Group has an exclusive licence to market this patented molecule developed by Dong-A Pharmaceuticals of Korea, in India, the company said in a statement here.
Zydus Cadila is one of the pioneers that launched Viagra-clones in India about a decade ago.
PDE5 inhibitors are the first line therapy for ED. Only two molecules, Sildenafil and Tadalafil from this group are currently available for the treatment of ED in India. Sildenafil has a rapid onset of action but its duration is shorter. Tadalafil has a longer duration of action but is associated with side effects of muscle pain and back pain.
Udenafil has been found efficacious in the treatment of various causes and severity of ED with no muscle pain or back pain being reported in the clinical trials. Rapid onset and longer duration of action are the unique features of Udenafil. The treatment with this therapy has shown significant improvement in erections in ED patients with hypertension or diabetes mellitus in specific clinical studies.
Erectile dysfunction is said to affect about 10% of the male population. The incidence is fairly common in men above the age of 40 with nearly 52% of men in this age group being affected with this disorder. The number of males suffering from ED is estimated to exceed 320 million men worldwide by the year 2025, with the largest projected increases in developing continents such as Africa, Asia, and South America.
Udzire is a new addition to the current management of ED and will assist medical practitioners in customising treatment regimens to the unique needs of the patients with ED in India, the company added.
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