For anyone who has ever experienced or witnessed the debilitating effects of period pain, they’ll be glad to know that the suffering may soon be at an end. Vantia Therapeutics has announced that its new development, an oral small molecule drug for now known simply as VA111913, has entered its second phase of testing as a treatment for dysmenorrhoea (painful menstruation). If results are successful the drug could be available for commercial use within four years.
Millions of women currently rely on over-the-counter painkillers and “off-label” contraceptive drugs to offer temporary relief, but nothing as yet is available to completely eliminate menstrual pain for the duration of each cycle.
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Preclinical trials have shown that VA111913 normalizes muscle contraction that causes abdominal cramping during menstruation. Abdominal cramps are due to the presence of the hormone vasopressin, which causes the smooth muscle of the uterus wall to contract. Dysmenorrhoea occurs when vasopressin levels are excessively elevated, precipitating pains so severe that basic daily activities such as getting to work or school become insurmountable. The drug alleviates pain by blocking vasopressin 1a receptors in smooth muscle tissue in the uterus wall, potentially making it the first drug to directly target the cause of dysmenorrhoea.
So far the drug has tested successfully, with results of the Phase I study, comprising a single ascending dose phase, multiple ascending dose phase, and a food study, showing it to be safe and well tolerated by subjects, with no serious adverse effects reported during the study.
Phase II will trial 128 women aged between 18 and 25 in the UK and the US. Subjects will be dosed with VA111913 and placebo in a cross over design over two consecutive menstrual cycles. The results, which will be based on subjects’ assessments of pain, bleeding and amount of analgesia required to treat symptoms, are expected for review in 2010.
Given that period pain affects at least 80 per cent of women, the market presents an overwhelming demand for a product that could potentially make menstruation pain-free, an opportunity that could generate at least $1 billion per year in doing so, according to Vantia Therapeutics.
And while to some it may seem like substituting one form of medication for another, Dr. Jim Phillips, CEO of the UK-based pharmaceutical company believes that this product “could offer an effective alternative” to current over-the-counter remedies. Exactly how effective it will be compared to more trusted options will remain to be seen.
Further details of the trial and study can be found at clinicaltrial.gov.
Via Daily Mail.