Objective: To assess the real-world safety profile of Gocovri® (amantadine) extended release capsules one year post-launch.

Background: Gocovri received FDA approval in August 2017 for dyskinesia in Parkinson’s disease (PD), with full commercial launch in January 2018. Gocovri is dispensed through specialty pharmacies whose representatives contact patients by phone on a monthly basis. All potential adverse events (AEs) reported during these calls are considered solicited and entered into a database.

Method: First-year post-launch safety reporting for Gocovri was compared with the safety reporting in the phase 3 clinical trials.

Results: Post-launch adverse event (AE) rates were comparable to, and generally less than, AE rates in phase 3 studies, with Hallucination the most frequently reported (17% post-launch vs 21% phase 3). The post-launch hallucination rate for Gocovri is consistent with the 15% rate estimated for immediate release amantadine in an authoritative review (Parkes, 1981). Six MedDRA AE terms were reported at ≥3% post-launch that had lower rates in phase 3, 2 PD related (Balance disorder 6%; Tremor 5%), 3 relating to overall energy/strength (Fatigue 7%, Somnolence 5%, Asthenia 3%) and 1 nonspecific (Feel Abnormal 3%). Clinically relevant AEs, observed at <3% in phase 3, included, Delusions, Paranoia, Suicidality, and Apathy; post-launch rates were 1, 0.4, 0.2, and 0.1%, respectively. No post-launch AEs of neuroleptic malignant-like syndrome were reported. Fatalities in phase 3 were too few to provide a basis for comparison, but post-launch rates were consistent with literature-reported rates in PD. Most post-launch AEs showed an age-event relationship and were experienced by patients receiving 274 mg of Gocovri, irrespective of age. Preliminary investigations did not reveal any conspicuous associations between specific AEs and medical history or concomitant medications.

Conclusion: Post-launch AEs closely parallel the AE profile from phase 3. This may be due in part to frequent contact between specialty pharmacy and patient. The association between AE rates and age highlights the importance of dose adjustment for patients with age-related renal impairment and raises the possibility of other factors contributing to reduced tolerability with age. Dosing at <274 mg should be considered in patients who may be at heightened risk for AEs.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/safety-of-gocovri-in-clinical-practice-one-year-post-launch-pharmacovigilance-data/