Nonhormonal Hot Flash Therapy Meets Phase III Goals
Noven Pharmaceuticals reported positive data from separate 12- and 24-week Phase III trials evaluating low-dose mesylate salt of paroxetine (LDMP; 7.5 mg/day) for reducing the frequency and severity of moderate-to-severe vasomotor symptoms (VMS) associated with the menopause (i.e., hot flashes and night sweats). Both studies showed LDMP therapy reduced the frequency of menopausal VMS, and in the 24-week trial the drug also significantly reduced the severity of VMS symptoms at week 12.
The placebo-controlled studies evaluated LDMP in a total of over 1,100 women aged at least 40 years who were experiencing more than 7–8 moderate-to-severe hot flashes daily, or 50–60 per week prior to the study start. “Women often report hot flashes as the most common symptom associated with menopause, yet, there has been a decline in the use of hormone therapy among women seeking treatment for menopausal VMS,” states Andrew M. Kaunitz, M.D. professor and associate chair at the University of Florida College of Medicine’s department of obstetrics and gynecology. “LDMP was specifically developed for the treatment of menopausal VMS. It appears to be effective and well-tolerated, and, if approved by FDA, it could be the first nonhormonal option available for women."
At the end of August Noven Pharmaceuticals submitted an NDA to FDA for use of LDMP in the menopausal VMS indication. The firm is a subsidiary of Hisamitsu Pharmaceutical.