58th Annual Meeting of the American Academy of Neurology: New Sumatriptan Formulation for Acute Migraine

In: Main

5 Apr 2010

New Sumatriptan Formulation for Acute Migraine

Speaker: Roger Cady, MD, Director, Headache Care Center and Primary Care Network, Springfield, Missouri

A new formulation consisting of a fixed-dose, single tablet containing sumatriptan succinate 85 mg with RT Technology (Suma RT) with (NAP) (Suma RT/NAP) (Trexima, GlaxoSmithKline/Pozen) showed superior results in treating acute migraine pain compared with either the separate components or placebo. (Trexima is the proposed brand name for the combination, formulated with RT Technology, and naproxen canadian) Significantly more patients were “satisfied” or “very satisfied” with the combination compared with Suma RT, NAP, or placebo.

Initially, two identical, randomized, double-blind, placebo-controlled, parallel-group, single-attack (moderate or severe) multicenter studies of adult migraineurs were performed. Study I enrolled 1,470 patients, and study II enrolled 1,441 patients.

Patients were randomly assigned to receive Suma RT/NAP, Suma RT 85 mg, NAP 500 mg, or placebo. Primary endpoints were assessments of pain and associated symptoms.

The patients completed the eight-item Patient Perception of Migraine Questionnaire (PPMQ)—a previously validated treatment satisfaction testing instrument—at the baseline evaluation and at 24 hours after receiving the dose. The PPMQ used a 7-point scale (ranging from very unsatisfied to very satisfied) to measure:

  • relief of migraine pain
  • relief of other migraine symptoms
  • speed of relief of pain or other migraine symptoms
  • drowsiness from the medication
  • duration of effect
  • doses needed for symptom relief
  • speed of return to usual activities
  • overall medication effectiveness

The percentage of patients who were satisfied or very satisfied with Suma RT/NAP was consistently higher than the percentage of those taking placebo for all PPMQ items in both studies (P < .001). The percentage was also consistently higher for the active comparators (Suma RT and NAP) for all PPMQ items (P < .05) except for drowsiness in study I. In both trials, Suma RT/NAP provided better two-hour and four-hour pain relief compared with Suma RT, NAP, and placebo. More migraineurs in the Suma RT/NAP group reported satisfaction with this agent compared with their previous treatment.

Botulinum Toxin Type A for Migraine Prophylaxis

Speaker: Andrew Blumenfeld, MD, Director, The Headache Center of Southern California, Scripps Memorial Hospital, Encinitas, California

In a comparison of botulinum toxin type A (BoNT-A) (Botox, Allergan) and divalproex sodium (Abbott) to prevent episodic migraine, the two active treatments were similar in efficacy as migraine prophylaxis, but BoNT-A was more effective in reducing headache pain and demonstrated a superior safety and tolerability profile than divalproex.

Sixty patients were enrolled in a randomized, evaluator-masked, single-center study. To be enrolled in the study, they had to be experiencing at least two but less than eight migraine headaches per month. The patients were assigned to take 105 to 260 units of BoNT-A or 500 mg of divalproex twice daily. Efficacy was assessed by mean differences from baseline in Migraine Disability Assessment (MIDAS) scores. Patients

received treatment at day zero (0) and were evaluated at 30, 60, and 90 days. At day 90, the mean difference from baseline in MIDAS total scores was significantly greater with BoNT-A than with divalproex (-8.05 vs. -0.27; P = .0375). At day 0, the mean number of headache days was 11.60 with BoNT-A and 16.10 with divalproex (p = .074), from a baseline of 14.27 and 13.83, respectively.

At all times, the reduction in average headache pain was greater with BoNT-A than. Fewer adverse events appeared to be related to BoNT-A (nine) than to divalproex (21). None of the BoNT-A patients discontinued treatment as a result of adverse events, although six patients in the divalproex group stopped therapy.

 


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