Strongbridge Biopharma plc Announces Publication of Long-term Efficacy and Safety Results for KEVEYIS® (dichlorphenamide) for the Treatment of Primary Periodic Paralysis in Muscle & Nerve
~ Study Confirms Long-Term Treatment with KEVEYIS is Safe and Effective for Chronic Use ~
~ Analyses Provide Potentially Useful Information to Help Guide Clinician Patient Counseling & Management When Starting Treatment with KEVEYIS ~
“The published results from the post hoc analyses of the HYPHOP study extend the positive findings from the original KEVEYIS® (dichlorphenamide) HYPHOP study by demonstrating that efficacy was maintained over the entire 61-week study with no evidence of waning over time,” said
The open label extension results of HYPHOP add to previously reported results from the short-term randomized, double-blind, placebo-controlled phase of the study, with hyperkalemic and hypokalemic PPP sub-studies, which demonstrated the effectiveness of KEVEYIS to prevent attacks of muscle weakness.
Adverse event analyses indicated no new safety signals during the final 52 weeks of the study versus the first nine weeks, with the common adverse events of paresthesia and cognition impairment, reported at lower frequencies during the extension as compared with the first 9 weeks. Clinicians can advise patients starting KEVEYIS that most patients who had one of these events initially reported it within the first month of treatment. Temporary dose reduction appeared to be a reasonable approach to manage bothersome paresthesia or cognition-related AEs, as patients with these AEs who were managed with dosage reduction often had subsequent symptom resolution.
The manuscript, entitled “Long-term efficacy and safety of dichlorphenamide for treatment of primary periodic paralysis,” can be accessed here.
KEVEYIS® (dichlorphenamide) is indicated for the treatment of primary hyperkalemic periodic paralysis, primary hypokalemic periodic paralysis, and related variants. In clinical studies, the most common side effects of KEVEYIS were a numbness or tingling, difficulty thinking and paying attention, changes in taste, and confusion. These are not all of the possible side effects that you may experience with KEVEYIS. Talk to your doctor if you have any symptoms that bother you or do not go away. You are encouraged to report side effects to Strongbridge Biopharma at 1-855-324-8912, or to the FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch. For additional KEVEYIS important safety information and the full prescribing information visit www.keveyis.com.
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Source: Strongbridge Biopharma plc