New Schizophrenia Drug Shows Promise of Greater Success with Fewer Side Effects

More than 3 million Americans and 24 million people worldwide suffer from schizophrenia. Even with the amazing drugs available to them, they still suffer from symptoms as well as a wide range of side effects from the drugs used to treat them. But there’s a new hope. Brilaroxazine, a new drug in Phase 3 clinical trials, may finally offer be an effective, life-improving mental health treatment with significantly reduced side effects.

Brilaroxazine, developed by Reviva Pharmaceuticals Holdings, Inc., (NASDAQ: RVPH), is currently in phase 3 trials, and in successfully completed phase 2 trials has demonstrated a robust efficacy and a clean side-effect profile on par with placebo, and even boasted a lower drop-out rate than placebo. This is a gigantic step forward according to Laxminarayan Bhat, PhD, Founder, President and Chief Executive Officer of Reviva Pharmaceuticals.

“The millions of schizophrenia patients around the world have long suffered not only with their symptoms, but also with the side effects of the drugs being used today to treat those symptoms,” Dr. Bhat said. “Our drug, Brilaroxazine, has demonstrated through clinical phase 2 trials that it is not only comparable or superior in efficacy to the drugs they may already be taking, but it also reduces the side effects that lead to nearly 30-50 percent of schizophrenia patients being unsuccessful in their treatment. For many, the side effects are so comprehensive, that many take their meds inconsistently, or stop taking them completely.”

According to Web MD, the list of side effects associated with current schizophrenia drugs can be dizzying. They include:

• Drowsiness.
• Dizziness when you change positions.
• Dry mouth.
• Rapid heartbeat.
• Menstrual problems.
• Problems with sex.
• Enlarged breasts (even in males)
• Metabolic disorders—increase in body weight leading to obesity, increase in blood sugar leading to type 2 diabetes and increase lipids.
• Changes in breathing and heart rate.

Both older and newer antipsychotics may cause a rare condition called neuroleptic malignant syndrome. Symptoms include:

• Big swings in blood pressure.
• Muscle stiffness.

With long-term use, older and newer drugs may also cause a serious condition called tardive dyskinesia (TD). TD causes random muscle movements such as facial grimacing, lip smacking, and eye blinking. 

Moreover, according to the World Health Organization, schizophrenia is frequently associated with significant distress and impairment in personal, family, social, educational, occupational, and other relationships and important areas of life.

“People with schizophrenia are 2 to 3 times more likely to die early than the general population,” the WHO reports. “This is often due to physical illnesses, such as cardiovascular, metabolic, and infectious diseases. People with schizophrenia often experience human rights violations both inside mental health institutions and in community settings. Stigma against people with this condition is intense and widespread, causing social exclusion, and impacting their relationships with others, including family and friends. This contributes to discrimination, which in turn can limit access to general health care, education, housing, and employment.”

That’s why Dr. Bhat hopes to prove in phase 3 that brilaroxazine could be a silver bullet for schizophrenia patients.

“Maintaining a strict medication regimen is paramount for Schizophrenia patients to prevent and reduce the number of episodes,” Dr. Bhat added. “A medication that combines high efficacy and a cleaner side effect profile could help millions of patients stay on their meds more consistently and offer them a quality of life they’ve never enjoyed before. And so far in our phase 2 trials, it looks like brilaroxazine could deliver just that.”

Gary S. Goldman is the nationally recognized host of ‘Business, Politics, & Lifestyles’ a weekly talk show airing on WPRO in Providence RI. Learn more at garyonbpl.com.