Digital Tracking Pill, Expanded Indication for Schizophrenia Treatments Win FDA Approvals

FDA officials took 2 steps today that will extend and facilitate treatment options for patients with schizophrenia and other mental health conditions.

In one action, officials with the FDA approved an extended indication for cariprazine (Vraylar, Allergan) to include the maintenance treatment of adults with schizophrenia, according to an Allergan statement. Cariprazine was previously approved for use in adults for the acute treatment of schizophrenia and acute treatment of manic or mixed episodes of bipolar I disorder.

In another action, officials with the FDA approved the first drug in the US with a digital ingestion tracking system, aripiprazole tablets with sensor (Abilify MyCite). This product is approved for the treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder, and for use as an add-on treatment for depression in adults.

According to an FDA press release, the MyCite system works by sending a message from the pill’s sensor to a wearable patch. The patch transmits the information to a mobile application so that patients can track the ingestion of the medication on their smart phone. Patients can also permit their caregivers and physician to access the information through a web-based portal. It was noted in the press release that Abilify MyCite’s prescribing information notes that the ability of the product to improve patient compliance with their treatment regimen has not been shown. Abilify MyCite should not be used to track drug ingestion in “real-time” or during an emergency because detection may be delayed or may not occur.

Prior to initial patient use of the product, the patient’s health care professional should facilitate use of the drug, patch, and app to ensure the patient is capable and willing to use the system.

Abilify was first approved by the FDA in 2002 to treat schizophrenia. The ingestible sensor used in Abilify MyCite was first permitted for marketing by the FDA in 2012.

The FDA granted the approval of Abilify MyCite to Otsuka Pharmaceutical Co., Ltd. The sensor technology and patch are made by Proteus Digital Health.

Cariprazine is a once-daily atypical antipsychotic, with a recommended dose range of 3 to 6 mg/day for patients with bipolar I disorder, and a recommended dose range of 1.5 to 6 mg/day for adults with schizophrenia.

The supplemental new drug application approval was based on a 72-week study that demonstrated the prevention of relapse in adult patients with schizophrenia who used cariprazine. The study included a 20-week open-label phase where patients with schizophrenia were treated with cariprazine 3, 6, or 9 mg per day. Patients who responded and met the stabilization criteria during the open-label period were then randomized either to continue their cariprazine dose or be switched to placebo for up to 72 weeks or until relapse.

According to the findings, cariprazine significantly delayed the time to relapse, compared with placebo, with relapse occurring in nearly twice as many placebo-treated patients as those treated with cariprazine.

The safety results were consistent with the profile observed to-date for cariprazine.

References

1. Allergan receives FDA approval for use of Vraylar (cariprazine) in the maintenance treatment of schizophrenia [news release]. Dublin, Ireland; November 13, 2017. allergan.com/news/news/thomson-reuters/allergan-receives-fda-approval-for-use-of-vraylar. Accessed November 13, 2017.

2. FDA approves pill with sensor that digitally tracks if patients have ingested their medication [news release]. Washington, DC. Accessed November 13, 2017. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm584933.htm