Lundbeck, Inc.

THURSDAY, May 11, 2023 -- A medication to treat agitation in Alzheimer's patients now has approval from the U.S. Food and Drug Administration. The FDA gave supplemental approval to Otsuka Pharmaceutical Company Ltd., and Lundbeck Inc. for Rexulti (brexpiprazole) oral tablets on Thursday. Rexulti is the first FDA-approved treatment for these symptoms. “Agitation is one of the most common and challenging aspects of care among patients with dementia due to Alzheimer’s disease. ‘Agitation’ can include symptoms ranging from pacing or restlessness to verbal and physical aggression,” said Dr. Tiffany Farchione , director of the division of psychiatry in the FDA’s Center for Drug Evaluation and Research. “These symptoms are leading causes of assisted living or nursing home placement and have been associated with accelerated disease progression,” she added in an agency news release. The approval followed two 12-week studies. Participants were between 51 and 90 years of age, and had a probable diagnosis of Alzheimer’s dementia, along with the type, frequency and severity of agitation behaviors that require medication. Patients in the first study received either 1 or 2 milligrams (mg) of Rexulti. In the second study, they received 2 or 3 mg of Rexulti. Over the 12 weeks, researchers looked for a change from baseline in a patient's Cohen-Mansfield Agitation Inventory (CMAI) score. The inventory is a tool that uses caregivers' input to rate the frequency of agitation on a scale from one to seven. Patients who received 2 mg or 3 mg of Rexulti had statistically significant and clinically meaningful improvements in total CMAI scores compared to patients taking a placebo. Alzheimer’s disease is the most common form of dementia, a debilitating neurological condition with progressive decline. Many people with the condition require permanent at-home or residential care. More than 6.5 million Americans have Alzheimer’s disease. Agitation is a symptom that’s complex and stressful. The approval for Rexulti was made under the FDA's Fast Track designation, which speeds the review of drugs to treat serious conditions and satisfy an unmet medical need. Recommendations call for new patients to take 0.5 mg once daily on days one to seven. They should step up to 1 mg daily on days eight through 14, and then to 2 mg daily starting on day 15. The recommended target dose is 2 mg once daily. Possible side effects include headache, colds, dizziness, urinary tract infection and sleep disturbances. Rexulti will continue to carry a Boxed Warning designation for medications in this class. Elderly patients with dementia-related psychosis who are being treated with antipsychotic drugs are at an increased risk of death. Sources U.S. Food and Drug Administration, news release, May 11, 2023 Posted May 2023

SILVER SPRING, Md., May 11, 2023 /PRNewswire/ -- Today, the U.S. Food and Drug Administration is announcing the supplemental approval of Rexulti (brexpiprazole) oral tablets for the treatment of agitation associated with dementia due to Alzheimer's disease. This is the first FDA-approved treatment option for this indication. "Agitation is one of the most common and challenging aspects of care among patients with dementia due to Alzheimer's disease. 'Agitation' can include symptoms ranging from pacing or restlessness to verbal and physical aggression," said Tiffany Farchione, M.D., director of the Division of Psychiatry in the FDA's Center for Drug Evaluation and Research. "These symptoms are leading causes of assisted living or nursing home placement and have been associated with accelerated disease progression." Dementia is a serious and debilitating neurological condition characterized by progressive decline in one or more cognitive domains in the brain. Dementia can seriously impair an individual's ability to function independently. Many people living with dementia require permanent at-home or residential care. Alzheimer's disease is the most common cause of dementia. Alzheimer's disease is an irreversible, progressive brain disorder affecting more than 6.5 million Americans. Patients with dementia often have behavioral and psychological disturbances. Agitation is among the most persistent, complex, stressful, and costly aspects of care among patients with behavioral and psychological symptoms of dementia. The effectiveness of Rexulti for the treatment of agitation associated with dementia due to Alzheimer's disease was determined through two 12-week, randomized, double-blind, placebo-controlled, fixed-dose studies. In these studies, patients were required to have a probable diagnosis of Alzheimer's dementia; have a score between 5 to 22 on the Mini-Mental State Examination, a test that detects whether a person is experiencing cognitive impairment; and exhibit the type, frequency, and severity of agitation behaviors that require medication. Trial participants ranged between 51 to 90 years of age. In the first study patients received 1 or 2 milligrams (mg) of Rexulti; in the second study patients received 2 or 3 mg of Rexulti. The primary efficacy endpoint in these two studies was the change from baseline in the Cohen-Mansfield Agitation Inventory total (CMAI) score at week 12. CMAI is a survey tool that uses input from caregivers to rate the frequency of certain agitative behaviors in dementia patients on a scale from 1 to 7. In both studies, patients who received 2 mg or 3 mg of Rexulti showed statistically significant and clinically meaningful improvements in total CMAI scores compared to patients in the placebo group at week 12. The recommended starting dosage for the treatment of agitation associated with dementia due to Alzheimer's disease is 0.5 mg taken once daily on days 1 to 7. Patients should increase the dosage on days 8 through 14 to 1 mg once daily, and on day 15 to 2 mg once daily. The recommended target dose is 2 mg once daily. The dosage can be increased to the maximum recommended daily dosage of 3 mg once daily after at least 14 days, based on clinical response and tolerability. The most common side effects among patients with agitation associated with dementia due to Alzheimer's disease include headache, dizziness, urinary tract infection, nasopharyngitis, and sleep disturbances (both somnolence and insomnia). Rexulti will retain the Boxed Warning for medications in this class that elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. The FDA granted this application Fast Track designation. Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. The supplemental approval of Rexulti was granted to Otsuka Pharmaceutical Company Ltd., and Lundbeck Inc. Additional Resources: Alzheimer's Disease Approved Drugs: Questions and Answers The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

CUMBERLAND, Md., April 17, 2023 (GLOBE NEWSWIRE) -- RS BioTherapeutics, whose mission is to harness the therapeutic power of cannabinoids in the research, development, and commercialization of life changing medications, is pleased to announce that it has appointed pharmaceutical and consumer products veteran, Curtis R. Rhine as its Chief Financial Officer (CFO). Mr. Rhine is a finance leader with nearly 40 years of extensive experience across all finance disciplines including strategy, financial planning and analysis, long-term and short-term budgeting and forecasting, treasury including heavy bank financing experience, and accounting, financial reporting and tax. Mr. Rhine’s pharmaceutical experience includes serving as CFO of Ovation Pharmaceuticals where he readied them for acquisition by Lundbeck Inc. and Vice President, Finance of Takeda Pharmaceuticals North America (Takeda) where he oversaw all financial functions as the company grew annual revenues from launch to $3.5 billion. Prior to Takeda, Mr. Rhine spent 14 years at two divisions of PepsiCo, Inc. in financial and accounting roles of increasing scope and responsibility. Mr. Rhine has also served as CFO for the James Wood Family Office, Teasdale Latin Foods, and Radio Flyer. Commenting on the appointment of Mr. Rhine, Dean Hart, Chief Executive Officer of RS BioTherapeutics said, “We are very pleased to welcome Curtis Rhine as our new Chief Financial Officer. I had the great fortune of working with Curtis while at Takeda during a time of incredible growth and success. His skill as a finance leader is only matched by his cross-functional business acumen. Curtis is a seasoned financial leader with a unique combination of pharmaceutical and consumer products experience that will be of tremendous value as we navigate the development and commercialization of our pipeline.” Commenting on his appointment, Mr. Rhine said, “I’m excited to join RS BioTherapeutics as its CFO at this exciting time in the company’s history. The development of its first investigational compound, RSBT-001 as an alternative to corticosteroids in addressing exacerbation and preventing progression of both acute and chronic pulmonary inflammation presents tremendous commercial opportunities. I look forward to working closely with Dean and the rest of the RS BioTherapeutics team in moving RSBT-001 and RS BioTherapeutics into the future.” Mr. Rhine is a Certified Public Accountant (CPA) and earned his bachelor’s degree in Business Administration from Texas A&M University. About RS BioTherapeutics RS BioTherapeutics’ mission is to harness the therapeutic power of cannabinoids in the research, development, and commercialization of life-changing medicines. RS BioTherapeutics’ first investigational compound (RSBT-001) is a patent-pending, semi-synthetic cannabidiolic acid complex in development as an alternative to corticosteroids in addressing exacerbation and preventing progression of both acute and chronic pulmonary inflammation related to respiratory diseases including COPD, SARS-COV-2, Cystic Fibrosis, Asthma, Bronchitis, and Acute Respiratory Distress Syndrome. RS BioTherapeutics is targeting an IND filing for RSBT-001 in early 2025. More information on RS BioTherapeutics can be found at www.rsbiotherapeutics.com. Media Contact: David Gutierrez, Dresner Corporate Services for RS BioTherapeutics, (312) 780-7204, dgutierrez@dresnerco.com A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/14d98ce8-c48d-4115-a0a6-b9dbf9e1f108