Presentation: Safety and Tolerability of MQX-503, a Novel Investigational Topical Formulation of Nitroglycerin for the Treatment of Raynaud’s Phenomenon (2007)

26 Safety and Tolerability of MQX-503, a Novel Investigational Topical Formulation of Nitroglycerin for the Treatment of Raynaud’s Phenomenon

Purpose:
Currently available, commonly prescribed medications for Raynaud’s phenomenon, such as calcium channel blockers and nitroglycerin ointments, often cause adverse events such as headache, flushing, and lightheadedness. MQX-503 is a novel investigational nitroglycerin microemulsion formulation that is rapidly absorbed to induce local vasodilation.
Methods:
Data from 3 phase II and phase III studies using MQX-503 were analyzed for safety and tolerability. These studies enrolled subjects with primary or secondary Raynaud’s phenomenon at 20 sites in the United States and Canada who were treated for up to 4 weeks with MQX-503 or placebo.
Results:
In total, 271 subjects with Raynaud’s phenomenon, some of whom received both MQX-503 and placebo in a cross-over design, were available for safety evaluations in the 3 studies. 111 received MQX-503, 108 received placebo, and 52 received both. At least 1 adverse event was reported in 95 (35%) subjects treated with active drug and in 87 (32%) subjects treated with placebo. The most frequent adverse events included headache, dizziness, skin ulcer, and skin irritation. Overall, adverse events were not different between placebo and treated groups, and 99% were mild to moderate in nature. There were serious adverse events in 3 subjects - a subject on active and with lupus was admitted for pulmonary embolism and then subsequently re-admitted with pneumonia, a subject on placebo was admitted to the intensive care unit after a motor vehicle accident, and a subject treated with both active and placebo broke an ankle. No serious adverse events were determined by the study investigators to be related to treatment.
Conclusions:
MQX-503 appears to be acceptably safe when applied topically to individuals with Raynaud’s phenomenon.

 S.D. Sule, None; L. Hummers, None; L. Shapiro, None; D. Fiorentino, None; L. Chung, None; M. Baron, None; J. Shanahan, None; V. Hsu, None; N. Rothfield, None; V. Steen, None; R. Martin, None; C. Dugowson, None; E. Smith, None; M. Mayes, None; R. Simms, None; J. Pope, None; B. Kahaleh, None; M. Csuka, None; B. Gruber, None; D. Collier, None; N. Sweiss, None; L. Klaff, consultant, 5; F.J. Dechow, stocks, 1; employment, 3; J. Gregory, stocks, 1; employment, 3; F.M. Wigley, consultant, 5.