The approval last year of two new products – Alkermes plc’s Lybalvi and Intra-Cellular Therapies, Inc.’s Caplyta – plus an impending US regulatory decision for BioXcel Therapeutics, Inc.’s novel treatment for agitation are shaking up a staid bipolar disorder market. More novel therapies are also in development or approaching the market for various symptoms of the mental illness, despite the many challenges to R&D in the field.
Bipolar disorder is characterized by fluctuating mood states such as mania and depression, interspersed with periods of wellbeing. After the US Food and Drug Administration approval of the mood stabilizer lithium in the 1970s, the treatment of dipolar disorder went on to be dominated by polypharmacy, with physicians prescribing a sometimes-burdensome combination of different treatments such as anticonvulsants, antidepressants and antipsychotics to address a range of symptoms
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