With generics eating into sales of three key drugs and a recent key setback in schizophrenia, new Lundbeck CEO Deborah Dunsire can finally enjoy a bit of good news: the Danish company’s blockbuster antipsychotic brexpiprazole has yielded success in a mid-stage study in patients with PTSD when given in combination with the antidepressant sertraline (Zoloft).
Initiated in 2017, the 12-week placebo-controlled phase II trial enrolled 321 patients and was designed to assess brexpiprazole as monotherapy, sertraline as monotherapy or the two as a combination therapy in adults with PTSD. Brexpiprazole, which is already approved for use in major depression and schizophrenia, is sold as Rexulti and was discovered by Japan’s Otsuka.
Compared to patients that received a placebo, the combination treatment induced a statistically significant (p<0.01) reduction in symptoms, the partners said. However, brexpiprazole alone came up short, with a p>0.35, as did sertraline monotherapy, which fared even worse clocking in a p>0.60.
Although brexpiprazole was well tolerated, there was one death in the placebo group, the companies added on Friday, saying that they planned to meet the FDA to discuss next steps for the program.
Last year, two late-stage studies testing brexpiprazole for agitation triggered by Alzheimer’s dementia threw up mixed data, with one study successful and the other deemed a failure. Meanwhile, late-stage data from two studies evaluating the use of brexpiprazole in manic episodes associated with bipolar disorder is expected in the first quarter of 2019.
Dunsire took over the reigns in July, and was quickly forced to contend with a phase III failure of the company’s schizophrenia drug candidate, Lu AF35700.
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