U.S. Prescriber and Payer Receptivity to Emerging Agents for Treatment-Resistant Depression Amid a Crowded and Increasingly Genericized Market | Physician & Payer Forum | US | 2014

Major depressive disorder (MDD) continues to be a highly prevalent psychiatric disorder. Over 5 million drug-treated MDD patients in the United States fail to respond adequately to treatment with one major class of antidepressant (stage 1 TRD), and just over two-thirds of stage 1 TRD patients fail treatment with two major classes of antidepressants (stage 2 TRD). Atypical antipsychotics—e.g., Abilify (Bristol-Myers Squibb/Otsuka Pharmaceutical’s aripiprazole), one of the few therapies approved for patients who do not respond adequately to antidepressant therapy—are increasingly used to augment antidepressants in TRD treatment. The unipolar depression market, including therapies approved for TRD, is a mature market with few remaining branded agents. Although opportunity remains for emerging drugs that can provide efficacy in TRD that is comparable to that of antipsychotic augmentation, marketers will be required to overcome reimbursement hurdles imposed by payers to ensure patient access.

Key products in the depression market include the following:

– Forest Laboratories/Pierre Fabre’s Fetzima (extended-release levomilnacipran), a serotonin and norepinephrine reuptake inhibitor (SNRI) that launched in December 2013 in the U.S. market for the treatment of MDD in adults.

– Takeda/Lundbeck’s Brintellix (vortioxetine), a serotonergic antidepressant that launched in January 2014 in the U.S. market for the treatment of MDD in adults.

– Sunovion’s Latuda (lurasidone), an atypical antipsychotic that launched for the treatment of depressive episodes associated with bipolar I disorder (bipolar depression) as monotherapy and as adjunctive therapy with lithium or valproate in July 2013 in the United States. This agent is also in clinical trials for MDD with mixed features (at least three symptoms of mania but an insufficient number of symptoms to qualify as mania).