Unregistered User If this is not your name, click here.
		Contact Us | Order Now | Journals | Bookstore | Register a colleague
	Select a ChannelAcneAIDS and HIVAllergy OtherAlzheimer'sAnaesthesiology OtherAngina Pectoris/MIAnxietyArthritis OtherAsthmaBack PainBacterial InfectionsBladder CancerBone Marrow TransplantationBreast CancerCardiology OtherCataractCell TransplantationCervical CancerCholesterol/Lipid disordersCirrhosisClinical PharmacologyColorectal CancerCongestive Heart FailureContact DermatitisContraceptionCOPDCystic FibrosisDental and Oral DisordersDepressionDermatology OtherDiabetesDialysisEating DisordersElbowEmergency MedicineEndocrinology OtherEpilepsyErectile DysfunctionFibromyalgiaGastro OtherGeneticsGenitourinary OtherGeriatricsGERD/GastritisGlaucomaH. Pylori/UlcerHaematology OtherHair LossHeadachesHepa/Biliary OtherHepatitisHipHRTHypertensionIBDImmunologyInfectious OtherInfertilityIntensive CareIrritable Bowel SyndromeKneeLeukemiasLiver CancerLung CancerLupusLymphomasMelanomaMenopauseMultiple Sclerosis Nephrology OtherNeurologic OtherNutritional / Metabolic OtherOb/Gyn OtherObesityOncology OtherOphth. OtherOphthalmic SurgeryOrgan TransplantationOrthopaedics OtherOsteoarthritisOsteoporosisOtitisOtorhino. OtherOvarian CancerPaediatricsPainPancreatic CancerParkinson'sPregnancyProstate CancerPsychiatry OtherPulmonary OtherRadiologyRenal CancerRenal FailureRespiratory InfectionsRheumatoid arthritisRheumatology OtherRhinitisSchizophreniaShoulderSleep ApnoeaSleep DisordersSpineStrokeSTDsSurgeryThyroid DisordersTransfusionTransplant Surgery OtherTraumaUrinary IncontinenceUrinary tract infectionsVaccinologyVascular DisordersViral Infections

SEARCH   News Bookstore Medline The Web Meetings & Congresses Complete Doctor's Guide    EXPLORE :    All News   All Webcasts   All Cases   All Meetings & Congresses   All Medical Resources New drugs / indications English Dictionary Medical Dictionary Thesaurus Warning | Privacy | Awards  Favourite Journals  Click here to choose your favourite journals  Favourite Sites  Click here to choose your favourite sites  Languages  Select languageEnglishFrançais

FDA Approves Calcitriol for Mild-to-Moderate Plaque Psoriasis NEW YORK -- February 3, 2009 -- The US Food and Drug Administration (FDA) has approved calcitriol (Vectical) ointment 3mcg/g for the treatment of mild-to-moderate plaque psoriasis in adults. "Because psoriasis is a chronic disease, topical products that are safe for extended use must fit within overall, long-term treatment regimens," said Mark Lebwohl, MD, Department of Dermatology, Mount Sinai School of Medicine, New York, New York. "The FDA approval of [calcitriol] ointment will provide doctors and patients with a new, effective tool that has been proven safe and well-tolerated throughout 52 weeks of continuous use in treating mild-to-moderate disease. A safe, effective long-term therapy is critical to improve overall outcomes for these patients." Approval was based on two 8-week studies of more than 800 patients that compared twice-daily doses of calcitriol ointment with a vehicle treatment. In the first study, improvements in mild-to-moderate plaque psoriasis severity were seen at week 2, with treatment effects sustained over the 8-week treatment period. By the end of the study, 34% of patients achieved treatment success (GSS clear/minimal), compared with 22% of those treated with vehicle. At 8 weeks, 23% of patients demonstrated success and showed a 2-grade improvement in disease severity. The second study showed similar efficacy results. Treatment-related adverse events were similar in both groups, with the primary side effects being lab test abnormality, urine abnormality, psoriasis, hypercalciuria, pruritus, and skin discomfort. In a long-term 52-week safety study, adverse events were similar to those in the two 8-week studies. In addition, while some transient increases in plasma calcium levels were reported in the studies, the drug was reported as demonstrating no significant clinical effects on calcium homeostasis when used continuously over a 52-week time period. SOURCE: WeissComm Partners E-mail this page to a friend or colleague! To print, use this version