SAN DIEGO - Neurocrine (NASDAQ:NBIX) Biosciences, Inc. (NASDAQ:NBIX) today announced that the U.S. Food and Drug Administration (FDA) has approved INGREZZA® SPRINKLE (valbenazine) capsules, a new formulation designed to assist adults with tardive dyskinesia and chorea associated with Huntington's disease who have difficulty swallowing. The new oral granules formulation can be sprinkled on soft food, providing an alternative to the traditional capsule form.
INGREZZA SPRINKLE offers the same dosages as the original capsule formulation—40 mg, 60 mg, and 80 mg—allowing healthcare providers to adjust the dosage based on patient response and tolerability. The FDA's decision was based on data demonstrating the bioequivalence and tolerability of INGREZZA SPRINKLE compared to the original INGREZZA capsules.
Tardive dyskinesia (TD) is a movement disorder characterized by uncontrollable, abnormal movements, often resulting from long-term use of certain psychiatric medications. It is estimated to affect around 600,000 people in the U.S. Similarly, Huntington's disease (HD), a neurodegenerative disorder, leads to involuntary movements known as chorea, affecting an estimated 41,000 U.S. adults.
Dr. Eiry W. Roberts, Chief Medical Officer at Neurocrine Biosciences, stated, "We developed INGREZZA SPRINKLE to make administration easier for patients who have difficulty swallowing or prefer not to take a capsule."
The company emphasized the importance of INGREZZA SPRINKLE's approval for patients who experience dysphagia—a common issue among those with chorea due to HD and those living with TD. Surveys indicated that a significant percentage of these patients and their caregivers reported challenges with swallowing due to involuntary movements.
While INGREZZA SPRINKLE does not cure the cause of involuntary movements or treat other symptoms of HD, such as cognitive or emotional issues, it is a treatment option for the specific movement disorders associated with these conditions.
Neurocrine Biosciences is a biopharmaceutical company focused on developing treatments for neurological, neuroendocrine, and neuropsychiatric disorders. The approval of INGREZZA SPRINKLE adds to their portfolio of FDA-approved treatments for movement disorders.
The most common side effects of INGREZZA SPRINKLE include sleepiness and tiredness, hives, rash, and sleep disturbances. The company advises patients to discuss their medical history with healthcare providers before starting treatment.
InvestingPro Insights
As Neurocrine Biosciences (NASDAQ:NBIX) celebrates the FDA's nod to INGREZZA SPRINKLE, investors are closely monitoring the company's financial health and market performance. The latest data from InvestingPro shows a robust market capitalization of 13.83 billion USD, reflecting investor confidence in the company's potential for growth.
With a P/E ratio standing at 53.9, and an adjusted P/E ratio for the last twelve months as of Q4 2023 at 40.57, Neurocrine Biosciences trades at a multiple that suggests investors are expecting continued earnings growth. This is supported by an InvestingPro Tip indicating that net income is anticipated to grow this year, providing a positive outlook for the company's profitability.
Moreover, the company's stock is characterized by low price volatility, which could be a reassuring sign for investors seeking stability in their investments. For those considering capitalizing on Neurocrine Biosciences' market performance, additional InvestingPro Tips are available, offering deeper insights into the company's valuation and financial health. By using coupon code PRONEWS24, readers can receive an extra 10% off a yearly or biyearly Pro and Pro+ subscription to access these valuable tips, which currently number over 15.
As the company progresses, the financial metrics and InvestingPro Tips suggest that Neurocrine Biosciences is in a strong position to leverage its latest FDA approval to potentially enhance its market standing and financial performance.
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