Mark Lerman, M.D., principal investigator and medical director at the Center for Psychiatric Research at Alexian Brothers Behavioral Health Hospital in Illinois, presented positive results from the clinical trial titled Paliperidone Palmitate Research in Demonstrating Effectiveness (PRIDE), which is funded by Janssen Pharmaceuticals, a subsidiary of Johnson and Johnson. The study is the first trial comparing the efficacy of Janssen’s once-monthly injectable antipsychotic Invega Sustenna with other daily oral schizophrenia medications in the context of “real-world” situations—such as comorbid substance abuse disorder or a recent incarceration—that are experienced by some patients with schizophrenia.
PRIDE evaluated more than 400 patients with schizophrenia who had been taken into the criminal justice system at least twice within the previous two years, with at least one such incident resulting in incarceration. The participants were randomized to receive Invega Sustenna or commonly prescribed oral antipsychotics, such as aripiprazole, olanzapine, or risperidone, for 15 months.
The findings, which were presented last month at the APA annual meeting, showed Invega Sustenna to be statistically superior in delaying relapse in patients with schizophrenia compared with other commonly used antipsychotics (416 days versus 226 days). In addition, risk for relapse was 1.4 times higher in the oral-medication group than the Invega Sustenna group. Side effects included injection-site pain, insomnia, weight gain, akathisia, and anxiety.
Lynn Starr, M.D., director of clinical development at Janssen, said in a press statement that the PRIDE study “helps address a critical need for all individuals living with schizophrenia by delaying relapse, even for those patients typically excluded from clinical trials, such as those with a history of incarceration and substance abuse.” The company is conducting phase 3 clinical trials of a three-month formulation of Invega Sustenna.
FDA Approves First Drug for Sleep-Wake Disorder In People Who Are Blind
The Food and Drug Administration (FDA) has approved a melatonin receptor agonist, Hetlioz (tasimelteon), to treat non-24-hour sleep-wake disorder—a chronic disorder in completely blind individuals whose body clock cannot distinguish between 24-hour light-dark cycles because light is unable to enter their eyes. This is the first medication for such condition approved by the FDA.
“Non-24-hour sleep-wake disorder can prevent blind individuals from following the normal daily schedule that we all take for granted,” said Eric Bastings, M.D, deputy director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “Hetlioz can improve the ability to sleep at night and to be active during the day.”
The effectiveness of Hetlioz was evaluated in two clinical trials with 104 participants who were totally blind. Treatment with the drug, compared with placebo, resulted in increased nighttime sleep and decreased daytime sleep durations. The most common side effects reported included headache, elevated liver enzymes in the blood, bizarre dreams, upper respiratory or urinary tract infection, and drowsiness.
Hetlioz was reviewed under the priority review process, which “provides for an expedited review of drugs that treat serious conditions and have the potential to provide significant improvement in safety or effectiveness of the treatment, diagnosis, or prevention of such serious conditions,” according to the FDA. Hetlioz is manufactured by Vanda Pharmaceuticals.
The FDA approved Evzio, a naloxone hydrochloride auto-injector, for emergency treatment of opioid overdose outside of hospital settings.
“Over the past 10 to 15 years, we have been experiencing a staggering epidemic of opioid overdose deaths,” Petros Levounis, M.D., M.A., chair of psychiatry at Rutgers New Jersey Medical School and a member of the APA Council on Addiction Psychiatry, said in an interview with Psychiatric News. “The approval of a naloxone auto-injector. . .will make a big difference in saving lives. It essentially gives patients, their friends, and their families the power to instantaneously reverse a near-fatal event.”
Evzio, which is injected into muscle or under the skin, rapidly delivers the equivalent of a single dose of naloxone injection from a standard syringe. Evzio injections can be easily administered by family members or caregivers of those with opioid addiction. Once the auto-injector is turned on, it provides verbal instructions to the user describing how to deliver the medication, similar to automated defibrillators. The FDA recommends that caregivers of people known to abuse opioids become familiar with the instructions or practice with a device trainer before use of the auto-injector is needed.
The FDA emphasizes that Evzio is not a substitute for immediate medical care and that the person administering Evzio should seek immediate medical attention on the patient’s behalf. Repeated Evzio injections may be needed, since naloxone may not work as long as opioids do.
Alkermes reported positive results in its phase 3 clinical trials for the once-monthly medication aripiprazole lauroxil, indicated for schizophrenia.
A total of 623 patients with schizophrenia were randomized to receive once-monthly intramuscular injections of aripiprazole lauroxil (441milligrams or 882 milligrams) or placebo for 12 weeks. Once in the body, aripiprazole lauroxil converts to aripiprazole, which is commercially known as Abilify.
Data analysis showed that patients given the drug had statically significant reductions in positive (hallucinations and delusions) and negative (depression and social withdrawal) symptoms, as assessed by the Positive and Negative Syndrome Scale. Reported side effects included insomnia, akathisia, and headache. The safety profile of aripiprazole lauroxil was similar to that reported with oral aripiprazole.
Based on the results of the phase 3 study, Alkermes plans to submit a New Drug Application to the FDA later this year.
On April 29, Bristol-Myers Squibb (BMS) announced its acquisition of iPierian, a privately held biotechnology company focused on the development of new treatments for neurodegenerative disorders such as Alzheimer’s disease (AD). BMS paid $175 million for iPierian, with the potential for additional development and regulatory milestone payments totaling $550 million.
While the majority of therapeutic developments intended for AD have been aimed at reversing or halting build-up of amyloid-beta, iPierian has focused on developing drugs that reduce aggregation of Tau protein—in particular extracellular tau (eTau)—in the brain.
The recent acquisition gives BMS full rights to iPierian’s lead asset IPN007, a preclinical monoclonal antibody that represents a new approach to treating progressive supranuclear palsy, a neurodegenerative disorder that progresses much more quickly than AD but is also characterized by tau aggregation.
BMS plans to initiate phase 1 clinical trials with its newly acquired antibody in 2015.