Fervent Pharmaceuticals of Greenville has successfully submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration for FP-101, its proprietary lead drug candidate for treating menopause symptoms.

Fervent Pharmaceuticals

“Achievement of this regulatory milestone represents an important advancement in the development of FP-101, which we believe has the potential to bring relief to millions of women suffering from hot flashes, night sweats and insomnia associated with menopause,” said George Royster, founder, president and chief executive officer of Fervent.

Royster said the company would initiate a Phase 2a clinical trial to assess the therapeutic potential of FP-101 in post-menopausal women “suffering from a significant burden of hot flashes.” The trial will get under way in the first quarter of 2018 with top-line results expected in the second half of the year.

The trial will enroll 110 women at a dozen study sites in Illinois, North Carolina, South Carolina and Tennessee. The North Carolina sites are in Cary, Charlotte, Hickory, Raleigh, Rocky Mount, Salisbury, Wilmington and Winston-Salem.

Fervent is working with the University of Iowa Pharmaceuticals on drug formulation and with IQVIA (formerly QuintilesIMS) of Durham and PMG Research of Winston-Salem for clinical trial design and execution, Royster said.

FP-101 is an orally dosed, non-hormonal, non-herbal, non-antidepressant formulation of a compound that has known mechanisms of action, is already FDA approved for another undisclosed indication and has a long history of safe use. Its potential for treating the symptoms of menopause was discovered through “serendipity and a keen eye for detail and observation,” Royster said.

Menopause marks the end of a woman’s reproductive capacity as she ages and stops releasing eggs each month through menstruation. Unwanted symptoms caused by hormonal changes can start occurring before or after menopause and last for several years.

Symptoms include the sudden sensations of intense heat, palpitations, irritability, skin reddening, and perspiration. They can cause sleep deprivation and interfere with work and lifestyle.

Most FDA-approved treatments of symptoms in post-menopausal women involve estrogen hormone replacement therapy, which carries an increased risk of heart disease, breast cancer, deep vein thrombosis, stroke and gall bladder disease.

Development of safe and effective new therapies would fill a significant unmet medical need. The U.S. market for a therapy includes 32 million women, and the global market encompasses 115 million women. The total market “is in the multi-billion-dollar arena,” Royster said.

Fervent is a clinical-stage drug development company founded in 2011. It is focused on developing therapies targeting unmet medical needs in women’s health.

The company has received assistance from the North Carolina Biotechnology Center and its Eastern Regional Office, headed by Mark Phillips, vice president of statewide operations and executive director of the office.

“The expertise and networking assistance provided by Mark and the Biotechnology Center have been very helpful to our company’s growth and development,” Royster said.

(C) N.C. Biotechnology Center