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For episodic migraine prophylaxis, long-term use of 60 mg Atogepant once daily-dose is well-tolerated and safe.
A 40-week, open-label extension study showed that 60 mg oral Atogepant once daily-dose has a good safety and tolerability profile when used over the long term for preventive treatment of episodic migraine. Researchers sought to assess the Atogepant's long-term safety and tolerability in subjects who completed the phase 3 ADVANCE study.
Safety was assessed in subjects taking 60 mg Atogepant orally once a day. This was followed by a four-week safety follow-up period. In individuals with episodic migraine, the assessment of tolerability and safety of therapy with oral 60 mg Atogepant tablets, taken once a day for prophylaxis of migraine was the major endpoint ascertained.
Out of 685 subjects who were taking a minimum 1 dosage of Atogepant, 74.6% concluded the treatment period, with a mean (standard deviation) treatment length of 233.6 (89.3) days. Infections of the upper respiratory tract (5.5%), urinary tract infection (5.3%), sinusitis (3.6%), nasopharyngitis (4.8%), constipation (3.4%), and nausea (3.4%) occurring at ≥3% were among the treatment-emergent adverse events that occurred in 62.5% of patients.
There were no fatalities and only 3.4% of patients experienced serious adverse events that were not related to their therapy. Adverse events occurring at >0.1% that were severe enough to cause cessation were migraine, weight loss, vomiting, stomach discomfort, dizziness (0.3% each) and nausea (0.4%). The results were consistent with the drug's established safety profile and supported long-term usage of 60 mg Atogepant once-daily dosing as well-tolerated and safe.
Cephalalgia
Safety and tolerability results of atogepant for the preventive treatment of episodic migraine from a 40-week, open-label multicenter extension of the phase 3 ADVANCE trial
Brad C Klein et al.
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