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Jan 24, 2011

FDA Clears Clinical Data’s Oral Therapy for Major Depressive Disorder

  • FDA has cleared Clinical Data’s Viibryd™ (vilazodone HCl tablets) as a treatment for major depressive disorder (MDD) in adults. The firm claims the drug is the first selective serotonin reuptake inhibitor (SSRI) and partial 5HT1A receptor partial agonist to achieve approval in the U.S.

    Clinical Data developed Viibryd under an exclusive worldwide license from Merck KGaA. “It is also the first drug that the company has developed,” comments Drew Fromkin, Clinical Data CEO. “To have received marketing approval from FDA on its first review is a significant milestone.”

    The efficacy of Viibryd was established through two eight-week multicenter placebo-controlled studies in adults who met the criteria for MDD. Compared with patients given placebo, those receiving Viibryd experienced significant improvements in depressive symptoms measured by the Montgomery-Asberg Depression Rating Scale. Clinical Data points out that the exact mechanism of action of combined SSRI and partial 5HT1A antagonism effected by Viibryd is not yet fully understood.

    In November 2010 Clinical Data inked a deal to sell its genetic and pharmacogenomic testing and biomarker development business to Transgenomic, for approximately $15.4 million. The acquisition, completed in December 2010, represented the last stage in the firm’s decision to transform itself into a true pharmaceutical company. Its clinical pipeline, headed by Viibryd, includes the Phase III-stage coronary vasodilator Stedivaze (apadenoson). Stedivase is an adenosine A2A receptor selective agonist in development for use as a pharmacologic stress agent used with radionuclide myocardial perfusion imaging.

    Also in clinical development is PRX-8066, a selective 5-HT2B receptor antagonist currently in Phase II development, which has been granted orphan drug designation in the U.S. for the treatment of patients with pulmonary arterial hypertension. Clinical Data’s preclinical pipeline includes candidates for the treatment of diabetes, asthma, glaucoma, pain, b-cell cancers, and acute inflammation. The asthma/type 2 diabetes candidate, ATL844, is a selective adenosine A2B receptor antagonist, to which Novartis has an option for both potential indications.


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