The U.S FDA has approved 21mg and 10.5mg CAPYLTA capsules that Intra-Cellular Therapies Inc (NASDAQ: ITCI) made. The two new doses are for patients using moderate or strong CYP3A4 inhibitors. The 21mg dose could be for severe or moderate hepatic impairment patients.
According to Intra-Cellular Therapies’ CEO and Executive VP, Suresh Durgam, M.D., a 42mg dose of CAPLYTA is highly effective for patients with schizophrenia and bipolar disorder. The medication is taken once daily regardless of food intake.
CAPLYTA treats bipolar disorder and schizophrenia
Dr Durgam adds that the company’s new drug label recommends specific doses for patients with certain needs. He adds that the label could help healthcare providers prescribe the right dose per the patient’s needs. The company hopes to have the new doses out by the middle of the year.
The company developed the drug to treat bipolar depression in patients with Bipolar I or II. CAPLYTA can be taken alone or with standard therapies like valproate and lithium. The drug’s label gives certain warnings to patients.
Contraindications for the drug
One of the warnings is that the drug shouldn’t be given to elderly patients with psychosis brought about by dementia as it will increase their likelihood of death. Moreover, healthcare providers should monitor younger patients on antidepressants as it could increase their likelihood of having suicidal behaviours and thoughts. The efficacy of the drug hasn’t also been tested in children.
The drug is also not for patients with allergies to any of the ingredients in CAPLYTA, including lumateperone. Patients who react to the drug could experience urticaria, pruritus or rash. In addition, antipsychotic medication could cause tardive dyskinesia.
This is a syndrome where a patient has uncontrollable movements in different body parts, including the tongue and face. The symptoms could worsen with the duration of therapy and increased dose. Unfortunately, the symptoms could remain even after the patient stops taking CAPLYTA.
The drug could also cause mild or fatal cases of agranulocytosis, neutropenia, and leukopenia. The company recommends performing a cell count in patients with a history of these symptoms before administering the drug. If the patient experiences a decline in the parameters while taking the drug, the healthcare provider should cease treatment.
