The new oral pill seeks to address low testosterone levels – the underlying cause of decreased libido in men.
A new testosterone pill for men with low sex drive from Lipocine will be marketed worldwide by Solvay Pharmaceutical Inc.
Solvay Pharmaceuticals Inc, based in Marietta, Georgia has reached a development and commercialization agreement with Lipocaine for the oral testosterone pill.
Solvay will get the licence to exclusively sell the testosterone pill which is currently under development.
Lipocine’s investigational testosterone drug will be studied by further by Solvay to develop as an oral treatment for low sex drive and other related conditions in men associated with inadequate levels of testosterone hormone – a condition also known as male hypogonadism.
“This agreement further demonstrates Solvay Pharmaceuticals’ commitment to men suffering from low testosterone,” said Stephen Hill, president of Solvay Pharmaceuticals, in a statement. “As the market leader in the field, we will apply our expertise in the treatment of low testosterone to the development of an oral testosterone replacement therapy. This compound has the potential to be the next major innovation in the management of low testosterone.”
Lipocine, in return, will receive upfront payment and future milestone payments and royalties based upon product sales from Solvay Pharmaceuticals. Solvay Pharmaceuticals will also fund Lipocine development expenses associated with the programme. The payment amounts were not disclosed.
The new testosterone pill uses Lipocine’s proprietary oral Lip’ral technology. Lip’ral is a clinically proven oral delivery technology for water insoluble drugs. Water insoluble drugs present significant challenges in product design and compliance, including:
poor bioavailability leading to high dose and/or multiple dosage units per dose; highly variable pharmacokinetics leading to inadequate therapy and/or safety concerns; significant food effects on bioavailability leading to dosing restrictions in labeling and consequent patient compliance problems and slow or delayed absorption leading to inadequate drug dissolution/solubilization and consequent inconsistent bioavailability.
Lip’ral technology is based on lipidic compositions which form the optimal dispersed phase in the gastrointestinal environment for improved absorption of the insoluble drug. Lip’ral presents insoluble drugs efficiently to the intestinal absorption site, thus bringing the absorption process under formulation control and making the product robust to physiological variables such as dilution, pH, and food effects.
In some cases, solubilization in the dispersed phase can also improve aqueous stability allowing for improved gastrointestinal residence time of highly unstable drug molecules.
Lip’ral can also be extended with Lipocine’s Synchronized Solubilizer Release technology, Lip’ral-SSR, to enable controlled release of insoluble drugs and drugs with pH-sensitive solubility.
Low testosterone or hypogonadism affects more than 13 million men in the United States age 45 and older.Signs and symptoms of low testosterone may include low sex drive, erectile dysfunction, fatigue, depressed mood, reduced muscle mass and strength, increased fat body mass and decreased bone mineral density. Because signs and symptoms of low testosterone are subtle and often overlap with other common medical conditions, low testosterone is frequently undiagnosed.
Lipocine Inc. is a privately held pharmaceutical company leveraging its proprietary drug delivery technologies to commercialize innovative pharmaceutical products.
Solvay Pharmaceuticals, Inc., of Marietta, Georgia, is the U.S. subsidiary of Solvay Pharmaceuticals.Solvay Pharmaceuticals is a research driven group of companies that focuses on the therapeutic areas of neuroscience, cardiometabolic, influenza vaccines, gastroenterology and men’s and women’s health. Solvay registered sales of EUR 2.7 billion in 2008.