Global Health Ventures Reports Completion of Stability Test for X-Excite
25.10.10
(The "Company") is a
specialty pharmaceutical company focused on sublingual (under the
tongue) drug delivery. The Company is pleased to announce that it has
completed one month drug stability test as required by European
Regulatory Bodies for submission of X-Excite, the company's lead male
sexual enhancement drug. In order to submit the drug for approval
towards human trials, it is required that the Company provides drug
stability under two different conditions (25 and 40 degree
centigrade). Today, we are pleased to report that the results of the
study were positive and met all the criteria listed by the agency.
There has been no drug degradation or drug/excipients interaction
either at 25 degrees with 60% relative humidity (RH) or at 40 degrees
with 75% RH. Additionally, there has been no excipients degradation
or discoloration under either temperature. This study shows that our
product is remarkably stable and matches the best criteria for any
drug in the solid dosage form. The study was conducted by a third
party independent company under the International Committee of
Harmonization (ICH) guidelines. The Company has now completed all the
requirements to file with the European Regulatory Agency for
approval. Once the company files for approval, it shall take 30 to 60
days to get approval. The Company will then initiate human clinical
trials in Europe which shall take 2 to 3 months. After the completion
of human clinical trials, the Company will be in a strong position to
enter into partnership with a major pharmaceutical company who will
take further responsibility for additional clinical trials and
marketing of X-Excite.
Source: MarketWatch (press release)
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