The shares of Vanda Pharmaceuticals Inc. (NASDAQ: VNDA) demonstrated an upward trajectory in after-market trading, experiencing a notable surge of 30.43% to reach $5.10. This positive movement offset the decline observed during regular trading sessions, which concluded with a decrease of 5.10% settling at $3.91. The ascent in VNDA stock value on the US charts followed a significant regulatory endorsement.
Vanda Pharmaceuticals (VNDA) announced that Fanapt (iloperidone) tablets have been approved by the US Food and Drug Administration (FDA) for the treatment of acute episodes of bipolar I disorder in adults. An atypical antipsychotic drug, Fanapt, has been used for the acute treatment of schizophrenia since it was cleared by the FDA in 2009.
Bipolar I disease presents a variety of complex problems that must be addressed with a variety of reliable options tailored to each patient’s specific needs. With a collective experience exceeding 100,000 patient years, Fanapt emerges as a familiar therapeutic entity offering adaptable dosing alongside a well-established safety profile. The FDA’s decision opens up a new therapeutic option for individuals with bipolar I disease as well as medical professionals.
An estimated 2.8% of adult Americans suffer from bipolar disorder, a serious and common mental illness with 83% of cases being categorized as severe. This spectrum of disorders is characterized by alternating phases of elevated and depressed mood. The diagnostic criteria for bipolar I disorder mandates the occurrence of one or more episodes of mania, often accompanied by episodes of depression.
Patients exhibiting manic or mixed episodes in the context of bipolar I disorder represent a subset among the approximately 10 million Americans affected by the disorder. The regulatory green light for Fanapt in the context of bipolar I disorder, particularly with manic and mixed episodes, significantly augments the commercial prospects for the medication.
Despite advancements, a significant proportion of patients still grapple with finding efficacious treatment modalities for bipolar disorder. The customization of treatment to suit individual patient needs is pivotal for ensuring optimal care, rendering the approval of Fanapt a noteworthy milestone. Backed by a thoroughly scrutinized safety profile, Fanapt’s endorsement offers patients a novel and potent alternative for addressing the complexities inherent in managing this disorder.
