Veristat Assists EndoCeutics with NDA Submission for Intravaginal Prasterone
SOUTHBOROUGH, MA – September 15, 2015 – Veristat, a full service Clinical Research Organization (CRO), announced today the continuation of its partnership with EndoCeutics, a bio-pharmaceutical company that has seven investigational products in its portfolio to treat women’s health issues, and to prevent and treat hormone-sensitive cancers. Veristat is currently preparing all of the outputs for an NDA submission for Prasterone (DHEA) to treat Dyspareunia or pain at sexual activity, a symptom of Vulvovaginal Atrophy due to menopause.
Counting on Veristat for the preparation of our FDA Submission for Prasterone (DHEA) is the culmination of years of hard work and dedication by John Balser and his team,” commented Dr. Fernand Labrie, MD, PhD, Chief Executive Officer/Chief Scientific Officer of EndoCeutics, “I have truly come to rely on the clinical and statistical expertise of Veristat over the past decade. Veristat is practically an extension of my team as they have supported EndoCeutics for nearly every product in our pipeline.
“Veristat is committed to our partnership with EndoCeutics on their business critical NDA submission,” stated John Balser, PhD, President of Veristat. “Over the past decade, we have worked on six protocols for this submission, three of which were pivotal. We are currently compiling all the tables and supporting documentation for the NDA Submission. We are eager and encouraged to see this therapy submitted for FDA approval.”
EndoCeutics is a private bio-pharma company operating in the field of women’s health and hormone-sensitive cancer prevention and treatment. EndoCeutics' research focuses on developing non estrogen-based therapies for vulvovaginal atrophy, sexual dysfunction and the other symptoms of menopause including hot flushes, osteoporosis, muscle loss, type 2 diabetes, memory loss, cognition loss and possibly Alzheimer's disease. Hormonal therapies for breast, uterine and prostate cancer, male hypogonadism as well as endometriosis are also under development.
EndoCeutics has five Phase III product candidates addressing large market opportunities and two Phase I/II product candidates. EndoCeutics has exclusive worldwide rights to patents, patent applications, technology and know-how related to all its products. For more information, please visit www.endoceutics.com.
Claude Doré, Communications
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