Approval was based on two eight-week studies of more than 800 patients that compared twice-daily doses of Vectical ointment with a vehicle treatment.
According to the company, the Vectical ointment is the only vitamin D3 ointment of its kind available in the US. Vectical ointment contains calcitriol, the naturally-occurring, active form of vitamin D3, and is one of the only vitamin D3 products shown in clinical trials to be well-tolerated even when used on sensitive skin fold areas. Vectical ointment will be available by prescription in pharmacies in the first quarter of 2009.
Albert Draaijer, president of Americas at Galderma Laboratories, said: “Vectical ointment was developed in response to a need for more well- tolerated, long-term treatment options for mild-to-moderate plaque psoriasis. The development and launch of Vectical ointment in the US truly demonstrates Galderma’s continued commitment to dermatology patients.”