Three extended-release injectable formulations of second-generation antipsychotic drugs — two of risperidone (Rykindo, Uzedy) and one of aripiprazole (Abilify Asimtufii) — have been approved by the FDA for treatment of schizophrenia in adults. Rykindo and Abilify Asimtufii are also approved for maintenance treatment of bipolar I disorder in adults. Other extended-release injectable formulations of risperidone and aripiprazole have been available in the US for years (see Table 1).

The FDA has approved lumateperone (Caplyta — Intracellular Therapies), an oral second-generation antipsychotic, for once-daily treatment of schizophrenia in adults. It is the 13th second-generation antipsychotic drug to be approved by the FDA for this indication.

Bipolar disorder is characterized by episodes of mania, hypomania, and depression. Recurrences of manic or (more frequently) depressive symptoms are common. About 15-20% of patients with bipolar disorder die by suicide.

The FDA has approved Erzofri (Luye), an extended-release injectable formulation of the second-generation antipsychotic drug paliperidone palmitate, for treatment of schizophrenia and schizoaffective disorder in adults. It is the second once-monthly formulation of paliperidone palmitate to be approved in the US for these indications; Invega Sustenna was the first. Longer-acting injectable formulations of paliperidone palmitate are also available (see Table 1).

Invega Hafyera (Janssen), a long-acting, extended-release (ER) formulation of the second-generation antipsychotic paliperidone palmitate, has been approved by the FDA for twice-yearly IM treatment of schizophrenia in adults who have been adequately treated with another injectable ER formulation of the drug (Invega Sustenna or Invega Trinza). It is the first drug to become available in the US for twice-yearly treatment of schizophrenia.

The oral second-generation antipsychotic drug iloperidone (Fanapt – Vanda) has been approved by the FDA for acute treatment of manic or mixed episodes associated with bipolar I disorder in adults. First approved in 2009 for treatment of schizophrenia, iloperidone is the eighth second-generation antipsychotic to be approved for acute treatment of manic or mixed episodes of bipolar I disorder (see Table 1).

The FDA has approved a sublingual film formulation of the alpha-2 adrenergic receptor agonist dexmedetomidine (Igalmi — BioXcel Therapeutics) for acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults. It is the first alpha-2 agonist and the only sublingual film to be approved for this indication. Dexmedetomidine has been available for many years in an injectable formulation (Precedex) for sedation in the intensive care unit and to facilitate procedures such as mechanical ventilation.

The FDA has approved a long-acting fixed-dose combination of the stimulant dexmethylphenidate and the prodrug serdexmethylphenidate (Azstarys – Corium) for once-daily treatment of attention-deficit/hyperactivity disorder (ADHD) in patients ≥6 years old. Azstarys is the first product containing serdexmethylphenidate to become available in the US.

Alzheimer's disease (AD) is the most common cause of dementia, but cognitive decline is also associated with other neurological conditions such as Parkinson's disease, dementia with Lewy bodies, vascular dementia, and frontotemporal dementia.