The new patent pertains to the formulation’s use in connection with Premenstrual Syndrome (PMS) and premenstrual dysphoric disorder (PMDD). These sometimes debilitating conditions occur in some 15% of pre-menopausal women aged 25-44. The patent was approved for "compositions and methods for alleviating symptoms associated with premenstrual syndrome (PMS) and premenstrual dysphoric disorder (PMDD).”
Costly, debilitating syndromes
PMS is a combination of physical and emotional symptoms linked to the menstrual cycle. PMS symptoms occur 1 to 2 weeks before a woman's period. Up to 80% of women report having some symptoms prior to menstruation. These symptoms qualify as PMS in 20% to 30% of pre-menopausal women. According to the Medical University of South Carolina, current available treatments include SSRIs and other drug treatments that treat side effects and can cost from $60 to $535 per month.
More than 200 different symptoms have been associated with PMS, including emotional symptoms such as: stress, anxiety, insomnia, fatigue, mood swings, emotional sensitivity and/or changes in libido. Physical symptoms can include bloating, abdominal cramps, constipation, lower back pain, acne, breast swelling, muscle pain and others. PMDD consists of the same symptoms taken to an extreme level and includes mood swings severe enough to interrupt work and damage relationships.
David Rutenberg, CEO of Lipogen, told a group of visiting journalists at the company’s headquarters in northern Israel, that phosphatidylserine, one of three phospholipids the company manufacturers from soy lecithin, is a key component of cell membranes and intercellular communication.
“PS [phosphatidylserine] is involved with intracellular signaling. There’s a reason the body needs to produce this material; we don’t get it in our diet. Most people don’t eat brains,” he said.
“In our research we noted that PS is diminished when the body is under stress. We first applied for a patent on PS for the alleviation of stress, and not just physical stress but also psychological stress. Aging is a kind of stress,” he said.
Rutenberg spoke to a small contingent of international journalists, sponsored by the Israel Export Institute, at the company’s headquarters and production facility recently in the hills east of Haifa, in the northern part of the country. It’s where the company pioneered its water-based extraction process, which Rutenberg said is unique in the industry.
Unique process from vegetarian source
“Already in 1991 we knew getting PS from cow brain tissue was no longer possible because of mad cow disease,” Rutenberg said. The company worked out a proprietary, multi-stage process to derive the ingredient from soy. While other companies now use this raw material as well, Rutenberg said Lipogen’s ingredients are unique in that they use no solvents, which is his view can give rise to certain amounts of unidentified phospholipids as fellow travelers.
“According to our knowledge we are the only company using a water-based solution. There is no possibility of solvent residues, so we know our product is really safe and we know we don’t have any unknown phospholipids that may have been developed by using solvents,” he said.
Rutenberg said that PS and PA have followed a similar development path that other dietary supplement ingredients have in that as more players get into the market, the category trends toward commoditization. Rutenberg said Lipogen intends to combat that trend with its patents, further research, and with its simple yet refined production process.
“You see that now we are working on a basic, simple production line that is the result of all the work we put into the computerization of it. We have a high level of R&D that enables us to do things that other companies cannot do. Lipogen is really ready for price tensions in this market,” he said.
“And as for our patents, you have to back up patents with research. We are conducting a clinical trial on our formulation in Germany on PMS and PMDD and we expect results later in 2016,” Rutenberg said.