ME/CFS Primer/Education Milnacipran
Cypress (CYPB) and Forest Laboratories announced positive efficacy results from the third milnacipran Phase III trial in fibromyalgia syndrome (FMS).

Specifically, the “composite pain” responder analysis endpoint at 3 months showed that patients treated with milnacipran 100 mg daily were improved over placebo (p < 0.001) (BOCF imputation method). Additionally, the “composite syndrome” responder analysis endpoint at 3 months also showed a superiority of milnacipran over placebo (p < 0.001) (BOCF).

In our view, these strong results represent an undisputable proof of the efficacy of milnacipran in FMS. We believe that the milnacipran pivotal program is the largest ever undertaken in FMS and where the most information has been generated about the impact of a drug in the different domains of the syndrome. Although the FDA has previously indicated that all FMS drugs are likely to get the same label indication, we believe milnacipran has enough efficacy data to merit a differentiated efficacy label.

Our foremost concern with milnacipran has always been its cardiovascular safety, not its efficacy. This concern remains as in the third Phase III trial 5% of patients receiving the drug became hypertensive versus 1% of placebo patients. Additionally, 7% and 5% of patients receiving milnacipran experienced palpitations and tachycardia respectively versus 3% and 1% for placebo patients respectively.

Ladenburg Thalmann & Co.

New York, NY 10022