LEVITRA AND FDA APPROVAL

Bayer and Glaxosmithcline had signed a combined promotional and developmental agreement for Levitra in November 2001. The new medication which was introduced as the first ED drug to rival Viagra which was introduced in 1998. Levitra received regulatory approval for the treatment of penile dysfunction in over sixty-three countries. It was approved by the U.S. Food and Drug Administration as one of the first oral drugs for the treatment of erectile dysfunction in the month of August 2003.

Levitra was appraised in placebo-controlled trials involving more than 2000 men with erectile dysfunction, of which, two trials had erectile dysfunction as a consequence of diabetes mellitus or prostate cancer. The effectiveness of the new ED medication was evaluated by questionnaire in which the patients were asked about their sexual functioning. In all the trials FDA found that Levitra improved all patients' ability to achieve and maintain a strong penile erection. On 19 th August 2003 Levitra was approved by FDA as the second oral medication to treat erectile dysfunction or impotence.

FDA advised in its talk paper that the ED patients should undergo a thorough physical examination as well as medical history analysis by a registered health professional before taking Levitra. It is important to understand the original cause of the erectile dysfunction and to discover the suitable treatment for the same. It is also pointed out by FDA that Levitra does not protect from AIDS or any other sexually transmitted diseases (STDs).

The efficacy of Levitra to treat erectile dysfunction was enhanced by the fact that it has fewer side effects than Viagra and does not have any standing instance of vision problem called NAION. The most common side effects reported in clinical trials are flushing, headache, rhinitis, and dyspepsia. Two percent of the ED patient reported dizziness and in rare cases, a very small number of patients in that trial reported that they had blue tinge in vision.

The new erectile dysfunction therapy was introduced as a result of combined proficiency and expertise of two giants like GlaxoSmithKline and Bayer. Levitra is supposed to be more potent drug compared to Viagra as it was believed to work more efficiently than the diamond shaped blue pill. In other medical trials involving 1020 men with erectile dysfunction, the patients used Levitra for one year and the average success rate in erections improved to 87 % from 14 % and to 86 % from 16 % with the 10 mg dose and the 20 mg dose simultaneously. Levitra is available in as low dose as 2.5 mg where the lowest dose for Viagra is of 25 mg signifies that Levitra is a potent molecule which offers efficacy up to 24 hours. Andrew Witty, President, Europe , and GlaxoSmithKline had stated that they believed Levitra to offer increased satisfaction for many more men.