Invega Hafyera (paliperidone palmitate) Extended-Release Injectable Suspension for schizophrenia

In continuation of my update on paliperidone palmitate

The Janssen Pharmaceutical Companies of Johnson & Johnson announced the U.S. Food and Drug Administration (FDA)   approval of  long-acting atypical antipsychotic Invega Hafyera (6-month paliperidone palmitate), the first-and-only twice-yearly injectable for the treatment of schizophrenia in adults. Before transitioning to Invega Hafyera, patients must be adequately treated with Invega Sustenna (1-month paliperidone palmitate) for at least four months, or Invega Trinza (3-month paliperidone palmitate) for at least one 3-month injection cycle. 

The FDA approval of Invega Hafyera is based on the results of a 12-month, randomized, double-blind, non-inferiority Phase 3 global study that enrolled 702 adults (ages 18-70) living with schizophrenia from 20 countries. The results showed non-inferiority of Invega Hafyera compared to Invega Trinza on the primary endpoint of time to first relapse at the end of the 12-month period. Results found that 92.5 percent of patients treated with Invega Hafyera and 95 percent treated with Invega Trinza were relapse-free at 12 months.1 Relapse was defined as psychiatric hospitalization, increase in Positive and Negative Syndrome Scale [PANSS] total score, increase in individual PANSS item scores, self-injury, violent behavior, or suicidal/homicidal ideation.

The safety profile observed in the trial was consistent with previous studies of Invega Sustenna and Invega Trinza with no new safety signals emerging.1 The most common adverse reactions (≥5%) in the Invega Hafyera clinical trial were upper respiratory tract infection (12%), injection site reaction (11%), weight increase (9%), headache (7%), and parkinsonism (5%).

“Before I found the right treatment plan for me, my symptoms often got in the way of things that I loved to do,” said Patrick, an adult living with schizophrenia and a participant in the clinical trial. “But since my doctor introduced me to Janssen’s long-acting injectable options and my symptoms are controlled, I have the clarity to focus on the present, but also the stability to plan for my future.”

Schizophrenia is a complex and chronic brain disorder in which the symptoms and potential for relapse (or recurrence of symptoms) can impact many aspects of a person’s daily life. On average, an adult with schizophrenia experiences nine relapses in less than six years, often due to missed doses of medication. Adults living with schizophrenia and their loved ones face ongoing functional, emotional, and financial burdens. In addition, patients who experience more relapses may have more hospitalizations, which can lead to higher medical costs for patients, hospital systems, and payers.

“For too long, we’ve accepted relapse as a normal part of living with schizophrenia, while research continues to demonstrate that stronger medication adherence means better patient outcomes,” said Gustavo Alva*, M.D., DFAPA, Medical Director at ATP Clinical Research and 6-month paliperidone palmitate clinical trial investigator. “The Phase 3 trial results provide compelling evidence that 6-month paliperidone palmitate offers longer-term symptom control with the fewest doses per year, which may support greater patient adherence.”

Recently, the National Council for Mental Wellbeing and the American Psychiatric Association updated their schizophrenia treatment guidance and guidelines to expand the recommended use of long-acting injectables for appropriate adult patients living with schizophrenia.

Invega Hafyera is a long-acting injectable treatment that is administered by a healthcare provider in the upper buttocks area every six months. Invega Hafyera dissolves slowly into the bloodstream after injection, resulting in continuous treatment and symptom control over six months.

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https://en.wikipedia.org/wiki/Paliperidone

FDA Approves Secuado (asenapine) Transdermal System for the Treatment of Adults with Schizophrenia

In continuation of my update on Asenapine

Noven Pharmaceuticals, Inc., a wholly-owned subsidiary of Hisamitsu Pharmaceutical Co., Inc., has announced the U.S. Food and Drug Administration (FDA) has approval of  Secuado (asenapine) transdermal system, the first-and-only transdermal patch formulation for the treatment of adults with schizophrenia.As people living with schizophrenia cycle through treatments their therapeutic options narrow, leaving them and their caregivers looking for new treatment options,” said Leslie Citrome, M.D., M.P.H., Clinical Professor of Psychiatry and Behavioral Sciences, New York Medical College. “In addition to offering a new delivery option, transdermal patches can also provide caretakers and healthcare providers with a non-intrusive, visual confirmation that a treatment is being utilized.”

The once-daily transdermal drug delivery system (TDDS) provides sustained concentrations during wear time (24 hours)2 of the atypical antipsychotic drug asenapine, a well-established treatment for schizophrenia. A transdermal patch may help to mitigate some of the challenges patients face with the management of their schizophrenia.

“There is an enormous unmet need for new types of schizophrenia treatments, and Noven is committed to giving people living with this devastating disease and their family members new options that may help them effectively manage their symptoms,” said Dr. Naruhito Higo, Chairman and Chief Executive Officer, Noven Pharmaceuticals, Inc. “We commend the FDA on the approval of Secuado and look forward to bringing it to market in the U.S. as soon as possible so people living with schizophrenia have a transdermal delivery option for asenapine treatment.”

In the international, Phase 3, double-blind, placebo-controlled study, Secuado achieved the primary endpoint of statistically significant improvement from baseline in the change of the total Positive and Negative Syndrome Scale (PANSS) compared to placebo at week six. Efficacy and safety were assessed during the six-week treatment period in 616 adults living with schizophrenia. Additionally, Secuado demonstrated statistically significant improvement in Clinical Global Impression-Severity (CGI-S) scores, the key secondary endpoint of the Phase 3 study.

The systemic safety profile of Secuado was consistent with what is known for sublingual asenapine. The most commonly observed adverse reactions were extrapyramidal disorder, application site reaction, and weight gain. 

https://en.wikipedia.org/wiki/Asenapine

New study compares effectiveness of clozapine with standard antipsychotics in adults with schizophrenia

In real-world settings, patients with schizophrenia whose symptoms do not respond to standard antipsychotic medications have better outcomes if they are switched to clozapine instead of another standard antipsychotic. They have fewer hospitalizations, stay on the new medication longer, and are less likely to need to use additional antipsychotics. These findings were published today in the American Journal of Psychiatry.

Schizophrenia is a serious mental disorder affecting up to one percent of the adult population. Antipsychotics are effective at relieving symptoms for most patients, but up to 30% do not respond well to standard treatments and are considered to have treatment-resistant schizophrenia. While trials have indicated that clozapine is effective for these cases, the effectiveness of clozapine in clinical practice has not previously been studied in depth.

Often when one traditional antipsychotic medication does not work, clinicians change to another traditional antipsychotic. Clozapine is often seen as a drug of last resort, although it is the only medication approved by the FDA for treatment-resistant schizophrenia.

The new study was conducted using national Medicaid data from 6,246 patients whose treatment patterns were consistent with treatment resistance. It is the largest study directly comparing the effectiveness of clozapine with standard antipsychotics in this population in routine practice settings.

The results are encouraging and timely because the FDA recently broadened access to clozapine. In the past access was limited, in part because of the risk of agranulocytosis, a condition that can make people susceptible to infections. A system has been in place for 25 years to successfully manage the risks of agranulocytosis, using regular monitoring of white blood cell levels. Leading clinicians thus believe the limits on use of clozapine have been overly restrictive. The new FDA rules still require regular blood monitoring, but allow prescribers to make decisions based on benefits and risks for individual patients rather than rigidly following universal standards.

New study compares effectiveness of clozapine with standard antipsychotics in adults with schizophrenia