Emotional Brain has announced that the United States Patent and Trademark Office (USPTO) has awarded a new patent (US Patent No. 8,227,453, issued today) for its combination of a PDE5-inhibitor and testosterone for the treatment of Female Sexual Dysfunction (FSD).
There is no FDA-approved medicine available yet for this particular indication area, so American physicians annually prescribe off-label drugs for the treatment of FSD. Dr Adriaan Tuiten, PhD, CEO of Emotional Brain, explains, 'It ensures protection of our medical applications and medical procedures aimed at the treatment of Female Sexual Dysfunction. The issuance of new patents in a country such as the United States is tremendously important and has a huge impact.'
The award of this new patent removes one of the final barriers for Emotional Brain to press forward, after completion of the Phase 3 studies, to a successful market introduction of its therapeutic products.
Emotional Brain, based in Almere, the Netherlands, is a pharmaceutical company dedicated to the development of therapeutic products for the treatment of Female Sexual Dysfunction (FSD). In 2005, Emotional Brain started a research program into the causes of sexual complaints affecting women. In the course of this program, Emotional Brain's research team discovered that diminished sexual motivation and decreased sexual desire in women suffering from FSD may be caused by several factors. Following this discovery, a breakthrough was achieved with the development of two distinctive drugs.<p> These treatment options have different mechanisms of action to address the specific causes found to be at the basis of sexual complaints. Since then, both products have been extensively tested in test groups of Dutch and American women. The results of the trials thus far show a significant positive effect.<p> In order to obtain full FDA approval to market the products as prescription drugs in the United States, three trial phases have to be completed successfully. Emotional Brain is currently nearing completion of Phase 2B clinical trials of both treatment options.