Wyeth announces cream’s approval

Wyeth has announced that its pharmaceutical division’s Premarin vaginal cream 0.5 gm has been approved by the USA Food and Drugs Administration (FDA).

The product is used as a less frequent twice-weekly dosing regiment to treat moderate to severe postmenopausal dyspareunia.

The FDA’s approval follows efficacy results from a multi-centre clinical study that saw a 12 week randomised double-blind placebo phase and then a 40 week open-label phase.

Assistant vice president of global medical affairs at Wyeth Pharmaceuticals, Eileen Helzner, said: “This new indication for Premarin vaginal cream, with a low volume of 0.5g and two different dosing regimens ? gives health care professionals and women a new option in treating moderate to severe dyspareunia due to menopause.”

In other news, phase III data has found the 13-valent vaccine may broaden protection against pneumoccocal disease in children below two years old.

The data from the research was presented at the joint annual meeting of the Interscience Conference on Antimicrobial Agents and Chemotherapy and the Infectious Diseases Society of America in Washington DC, USA.

Speaking at the time, Emilio Emini, executive vice president at Wyeth Pharmaceuticals’ Vaccine Research and Development, said the vaccine has the potential to address a critical need that is currently not met.