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June 09, 2020
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Most patients report satisfaction with ALKS 3831 treatment in exit interviews

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Most ENLIGHTEN-2 extension study participants who completed exit interviews reported satisfaction with ALKS 3831 treatment, according to data presented at the American Society of Clinical Psychopharmacology Annual Meeting.

Adam Simmons

“Exit interviews can provide important supplemental information about an individual’s experience and can be highly informative in understanding the burden that is associated with the disease beyond what is determined by study endpoints or outcome measures,” Adam Simmons, MPH, director of clinical program management at Alkermes, told Healio Psychiatry. “In this qualitative study, we looked to capture the patient’s voice in an effort to better understand patient perception of disease burden and previous treatments, as well as experiences during the open-label extension study of investigational ALKS 3831.”

The ENLIGHTEN-2 extension study evaluated the safety of a combination of olanzapine and samidorphan, known as ALKS 3831 (Alkermes), as a long-term schizophrenia treatment. The researchers scheduled exit interviews within 60 days of completing or discontinuing the extension study for patients who entered a 4-week safety follow up. Experienced qualitative researchers used a semi-structured interview guide, developed based on feedback from experienced clinical investigators, to conduct the interviews.

Of 266 extension study patients, the researchers conducted exit interviews with 41 — 24 conducted in person and 17 via telephone or webcam. One patient had discontinued ALKS 3831 and 40 remained on treatment at the time of the interview. Mean time since being diagnosed with schizophrenia among interviewed patients was 15 years. Nearly three-quarters of patients (73.2%) were unemployed and more than half (56.1%) reported living with relatives or significant others.

Results showed patients were exposed to numerous pharmacologic agents over the course of their illness, including antipsychotics (95.1%), serotonin modulators (29.3%), selective serotonin reuptake inhibitors (26.8%), benzodiazepines (17.1%) and non-benzodiazepine hypnotics (14.6%). Most patients (78%) reported benefits with previous medications, including symptom alleviation, improved sleep and feeling calmer; however, these past experiences also included adverse events that impacted physical health, emotional or behavioral health and cognitive functioning. Patients reported lack of energy/drowsiness, weight gain, involuntary movements and change in mood as the most frequent adverse events of prior medications.

Regarding use of ALKS 3831, 23 patients reported adverse events, the most common of which were lack of energy (29.3%), dry mouth (12.2%) and dizziness (4.9%). Among 40 patients who rated their overall experience with ALKS 3831, all reported it as positive, with 60% “very satisfied” with the treatment. Most patients (85.4%) preferred to continue ALKS 3831 vs. switching to another medication.

The researchers noted that limitations of this research included possible overrepresentation of satisfied patients, potential missing data because of the semi-structured interview format, recall bias, and difficulty attributing specific health experiences as a symptom, impact or side effect of schizophrenia or medication among some patients.

“Findings from these exit interviews provide further data that may complement clinical assessments of efficacy and safety for investigational ALKS 3831,” Simmons told Healio Psychiatry. “Looking ahead, researchers may want to consider incorporating these types of qualitative assessments into pivotal study designs for the treatment of schizophrenia and bipolar 1 disorder as they could help provide a fuller understanding of the patient experience.”