Neurocrine Biosciences Presents Data on In Vitro Dissolution Performance of INGREZZA® (valbenazine) Capsule Contents via Soft Foods or Feeding Tube at AMDA - PALTC 2023 Annual Conference

SAN DIEGO, March 9, 2023 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced it will present data from three in vitro dissolution studies exploring the dissolution performance of INGREZZA® (valbenazine) capsule contents through soft foods or a gastrostomy (G-tube) feeding tube. The data (Poster #IND03, Valbenazine Capsule Contents for Potential Administration via Soft Food/Feeding Tube) will be presented at AMDA – The Society for Post-Acute and Long-Term Care Medicine's PALTC23 Annual Conference being held March 9-12 in Tampa, Florida.

The in vitro data demonstrated that crushing INGREZZA capsule contents did not impact dissolution performance when compared to whole capsules. Further, mixing the contents with soft foods or liquids of a broad pH range or delivering the contents dissolved in tap water via G-tube resulted in acceptable dissolution performance of INGREZZA.

"The data presented show that crushing the capsule contents of INGREZZA did not impact the dissolution performance in comparison to swallowing whole capsules in vitro," said Eiry W. Roberts, MD, Chief Medical Officer at Neurocrine Biosciences. "This information may be important for patients with tardive dyskinesia, especially those who are elderly, who may have trouble swallowing capsules because of their abnormal movements or other comorbid conditions."

Three studies were conducted to explore the potential of adding crushed INGREZZA capsule contents to soft foods or a gastrostomy feeding tube (G-tube):

• In Study 1, INGREZZA capsules could be opened manually, with the contents crushed between spoons. Very rapid and complete drug release (>98 percent in 15 minutes) was observed in all samples, independent of preparation (whole capsules or crushed contents) or dose (40 mg or 80 mg). For both doses, the average percentage release at first and last collection time points (10 minutes and 60 minutes, respectively) was similar for whole vs crushed in each of two commercial lots of INGREZZA (Lot-A, Lot-B) for the two doses (40 mg and 80 mg)
• In Study 2, recovery of crushed INGREZZA capsule contents was acceptable within 2 hours of adding them to the tested foods and buffers/fed state simulated gastric fluid (FeSSGF) (assay recovery range: 92 to 102 percent). Degradants of crushed contents in foods and buffers/FeSSGF were also within acceptable ranges
• Study 3 showed acceptable INGREZZA recovery following G-tube administration when crushed capsule contents were dissolved in hot or cold water and a cup rinse was performed (assay recovery range: 91 to 97 percent)

Neurocrine Biosciences will also present data on inappropriate use of anticholinergic medication for treating or preventing tardive dyskinesia (TD) in elderly patients [Poster #IND02, Treating Drug-Induced Movement Disorders with Anticholinergics: Implications for Elderly Patients].

The full abstracts being presented by Neurocrine Biosciences at AMDA-PALTC 2023 are available on the meeting website and can be accessed by registering.

About Tardive Dyskinesia (TD)

Tardive dyskinesia (TD) is a movement disorder that is characterized by uncontrollable, abnormal, and repetitive movements of the face, torso and/or other body parts, which may be disruptive and negatively impact patients. The condition is associated with taking certain kinds of mental health medicines (like antipsychotics) that help control dopamine receptors in the brain. Taking antipsychotics commonly prescribed to treat mental illnesses such as depression, bipolar disorder, schizophrenia and schizoaffective disorder, and certain medications to treat upset stomach, nausea, and vomiting are associated with TD. In patients with TD, these treatments are thought to result in irregular dopamine signaling in a region of the brain that controls movement. The symptoms of TD can be severe and are often persistent and irreversible. TD is estimated to affect approximately 600,000 people in the U.S.

About INGREZZA^® (valbenazine) Capsules

INGREZZA, a selective vesicular monoamine transporter 2 (VMAT2) inhibitor, is an FDA-approved product indicated for the treatment of adults with tardive dyskinesia, a condition associated with uncontrollable, abnormal, and repetitive movements of the face, torso, and/or other body parts.

INGREZZA is thought to work by reducing the amount of dopamine released in a region of the brain that controls movement and motor function, helping to regulate nerve signaling in adults with tardive dyskinesia. VMAT2 is a protein in the brain that packages neurotransmitters, such as dopamine, for transport and release in presynaptic neurons. INGREZZA, developed by Neurocrine Biosciences, is novel in that it selectively inhibits VMAT2 with no appreciable binding affinity for VMAT1, dopaminergic (including D2), serotonergic, adrenergic, histaminergic, or muscarinic receptors. Additionally, INGREZZA can be taken for the treatment of tardive dyskinesia as one capsule, once-daily, together with most psychiatric medications such as antipsychotics or antidepressants. INGREZZA dosages approved for use are 40 mg, 60 mg, and 80 mg capsules. INGREZZA is not approved in any other dosage form. INGREZZA is not an extended release so there are no restrictions on crushing INGREZZA in the approved labeling.

Important Information

Approved Use

INGREZZA^® (valbenazine) capsules is a prescription medicine used to treat adults with movements in the face, tongue, or other body parts that cannot be controlled (tardive dyskinesia).

It is not known if INGREZZA is safe and effective in children.

IMPORTANT SAFETY INFORMATION

Do not take INGREZZA if you:

• are allergic to valbenazine, or any of the ingredients in INGREZZA.

INGREZZA may cause serious side effects, including:

• Sleepiness (somnolence). Do not drive, operate heavy machinery, or do other dangerous activities until you know how INGREZZA affects you.
• Heart rhythm problems (QT prolongation). INGREZZA may cause a heart problem known as QT prolongation.

Symptoms of QT prolongation may include:

               •  fast, slow, or irregular heartbeat
               •  shortness of breath
               •  dizziness or fainting

Tell your healthcare provider right away if you have a change in your heartbeat (a fast or irregular heartbeat), or if you faint.

• Abnormal movements (Parkinson-like). Symptoms include: shaking, body stiffness, trouble moving or walking, or keeping your balance.

Before taking INGREZZA, tell your healthcare provider about all of your medical conditions including if you: have liver or heart problems, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

The most common side effect of INGREZZA is sleepiness (somnolence). Other side effects include changes in balance (balance problems, dizziness) or an increased risk of falls, headache, feelings of restlessness, dry mouth, constipation, and blurred vision.

These are not all of the possible side effects of INGREZZA. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch at www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see accompanying INGREZZA full Product Information.

About Neurocrine Biosciences

Neurocrine Biosciences is a neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs, but few options. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine, and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, Parkinson's disease, endometriosis,* and uterine fibroids,* as well as over a dozen mid- to late-stage clinical programs in multiple therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, Twitter, and Facebook. (*In collaboration with AbbVie).

Neurocrine, the Neurocrine logo, and INGREZZA are registered trademarks of Neurocrine Biosciences, Inc.

Forward-Looking Statements

In addition to historical facts, this press release contains forward-looking statements that involve a number of risks and uncertainties. These statements include, but are not limited to, statements regarding the potential benefits to be derived from INGREZZA and the value INGREZZA may bring to patients. Among the factors that could cause actual results to differ materially from those indicated in the forward-looking statements are: risks and uncertainties associated with the commercialization of INGREZZA; risks that clinical trial activities may not be predictive of real-world results or of results in subsequent clinical trials; risks that INGREZZA may be precluded from commercialization by the proprietary rights of third parties, or have unintended side effects or adverse reactions; risks and uncertainties relating to competitive products and technological changes that may limit demand for INGREZZA; risks associated with our dependence on third parties for development and manufacturing activities related to INGREZZA and our product candidates, and our ability to manage these third parties; risks that the FDA or other regulatory authorities may make adverse decisions regarding our products or product candidates; risks that our products, and/or our product candidates may be precluded from commercialization by the proprietary or regulatory rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; risks associated with potential generic entrants for our products; risks and uncertainties associated with the scale and duration of the COVID-19 pandemic and resulting global, national, and local economic and financial disruptions; and other risks described in the Company's periodic reports filed with the Securities and Exchange Commission, including without limitation the Company's quarterly report on Form 10-Q for the quarter ended December 31, 2022. Neurocrine Biosciences disclaims any obligation to update the statements contained in this press release after the date hereof.

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SOURCE Neurocrine Biosciences, Inc.