The US Food and Drug Administration (FDA) has granted fast-track approval of the first drug aimed at relieving the emotions associated with Alzheimer’s disease.
The FDA published, on its official website, a statement confirming the approval of Otsuka Pharmaceutical Company and Lundbeck, producers of oral Rexulti tablets to relieve the emotions associated with Alzheimer’s disease, reports Al-Qabas daily.
“Emotions associated with Alzheimer’s disease are one of the most challenging aspects of dementia patients,” said Dr. Tiffany Varcione, director of the division of psychiatry at the FDA’s Center for Drug Evaluation and Research. “It can include symptoms ranging from insomnia to verbal and physical aggression.”
“These symptoms have been associated with the accelerated progression of Alzheimer’s disease,” she added, in a press release from the agency.
Alzheimer’s disease is the most common form of dementia, a debilitating neurological condition with gradual deterioration. Many people with this condition require permanent care at home or in a residential setting. More than 6.5 million Americans suffer from Alzheimer’s disease.
Rexulti was approved after two 12-week studies in which participants were between 51 and 90 years old and had a possible diagnosis of Alzheimer’s dementia, along with the type, frequency and severity of arousal behaviors that required treatment. In the first study, patients received either 1 or 2 mg of Rexulti, and in the second study, 2 or 3 mg of the same drug.
Patients who received either 2 mg or 3 mg of Rexulti had statistically significant and clinically meaningful improvements compared to patients taking placebo.
Rexulti has been approved under the FDA’s fast-track designation, which speeds up review of drugs for serious conditions and medical needs.
Recommendations call for new patients to take 0.5 mg once daily on days 1 through 7, and the dose should increase to 1 mg daily on days 8 through 14, then to 2 mg daily starting on day 15, and the recommended dose is 2 mg once daily.