'In addition, we are pleased with the progress we have made in our other development programs, in particular our recent positive results with lumateperone for the treatment of bipolar depression
"In the second quarter of 2019, Allergan delivered steady growth in our key products including Botox, Vraylar, Juvederm, Lo Loestrin, and Ozurdex,vwhile we continued to advance our pipeline, highlighted by the FDA's approval of VRAYLAR (Cariprazine) for Bipolar Depression
and the NDA acceptance for Bimatoprost SR for Glaucoma," said Brent Saunders, CEO of Allergan.
In its depression program, data from the Phase 2 open-label study of SAGE-217 in bipolar depression
demonstrated rapid improvement compared to baseline; and analysis of datasets from previously completed studies revealed encouraging findings relevant to the development of SAGE-217 in treatment-resistant depression and generalized anxiety disorder.
Stephen Stahl, Professor of Psychiatry at the University of California San Diego and lead author of the post hoc analysis, Cariprazine Efficacy in Patients with Bipolar Depression
and Concurrent Manic Symptoms.
We also outlined what we consider to be the major clinical features of bipolar depression
and noted the role of thyroid hormones in managing mood disorders.
M2 EQUITYBITES-May 29, 2019-Allergan and Gedeon Richter wins US FDA approval of expanded use of VRAYLAR (cariprazine) in bipolar depression
M2 PHARMA-May 29, 2019-Allergan and Gedeon Richter wins US FDA approval of expanded use of VRAYLAR (cariprazine) in bipolar depression
After the Institutional Ethics Committee approved the study for its ethical aspects, 40 patients with bipolar depression
(all 40 patients had BID) and 40 patients with major depression were enrolled.
He said: "She has COPD (chronic obstructive pulmonary disease) and bipolar depression
, and this is making matters worse.
"The FDA approval of this medicine for the treatment of pediatric patients with bipolar depression
is significant for several reasons," Dr.
Patients who received lurasidone reportedly experienced improved bipolar depression
symptoms, compared with placebo, based on "the primary efficacy end point of change from baseline to week 6 on the Children's Depression Rating Scale-Revised total score (-21.0 vs.
Current treatments for major depressive disorder and bipolar depression
have major limitations with many patients do not responding to available antidepressant drugs.