Bloating, weight gain, mood swings, headaches. Just a handful of the not so lovely side effects bestowed upon women by the contraceptive pill.
After half a century, I think we can all agree that the pill is long overdue for a shake up. With more women than ever increasingly aware of what they put into their bodies, more and more of us are questioning the safety and necessity of the pill.
Not to mention: the side effects suck, having to remember to take it everyday sucks, getting new scripts sucks, the cost of it sucks.
Sure there are alternatives but not without their own crop of similar, annoying and potentially debilitating side effects.
We need more options that allow us autonomy over our bodies and enable highly individualised health-care from well informed providers.
Adding to the pool of contraceptive options is Mayne Pharma Group (ASX: MYX) and Mithra Pharmaceuticals. The companies have partnered to develop and launch NEXTSTELLIS®, a new oral contraceptive that uses E4, a novel estrogen with unique characteristics.
E4 is a natural estrogen that is highly specific in the body and has good oral bioavailability. The compound used in NEXTSTELLIS® is derived from a plant source and is the first new estrogen to be introduced in the US in over 50 years.
Following FDA approval in April of this year, NEXTSTELLIS® will now go on to compete in the hormonal oral contraceptive market valued at USD $3.5 billion in the US alone. It is estimated that 10 million women in America use oral contraceptives every day. The majority contain a synthetic estrogen that has broad binding ability within the body to all estrogen receptors, where E4 is more specific.
Mayne Pharma’s CEO, Scott Richards said: “ We are delighted to launch NEXTSTELLIS®, a new birth control option for women and their healthcare providers. Every woman’s body reacts differently to hormones and so from today, American women will now have a new choice of estrogen to consider when thinking about birth control options.
“Our key priorities with this launch are to educate the market on the benefits of NEXTSTELLIS® and the new estrogen E4, gain broad payor acceptance and reimbursement, and ultimately become the preferred branded oral contraceptive in the market. The launch is supported by a highly experienced national Women’s Health sales team that is now actively promoting NEXTSTELLIS® to healthcare providers.”
Mithra’s CEO, Leon Van Rompay said: “The launch of NEXTSTELLIS® today represents a new era in contraception and are proud to have played a part in helping to support women and their healthcare providers in the contraceptive choices. Mithra is excited to see the commercialisation of NEXTSTELLIS® in the world’s biggest pharmaceutical market.”
NEXTSTELLIS® is patent protected and has performed well in two phase 3 clinical studies conducted in almost 4000 women. Mayne Pharma holds a 20- year exclusive license to supply the US and Australia with the drug. In Australia, NEXTSTELLIS® is under review with the TGA and is yet to be approved.