Fibromyalgia Market Snapshot: Forest Delays Savella Launch
Executive Summary
Forest is delaying the launch of its recently approved fibromyalgia drug Savella (milnacipran) until at least May, when FDA is expected to okay a tablet-color change. Analysts do not anticipate the move will impact the drug's long-term sales when it joins Pfizer's Lyrica and Lilly's Cymbalta on the market
You may also be interested in...
Tonix Drops Fibromyalgia, Will Pursue PTSD Claim With Cyclobenzaprine Formulation
Failing to meet the primary endpoint of a Phase III trial of TNX-102 SL in fibromyalgia, cash-limited Tonix decides to focus on developing the drug for PTSD – which it thinks is the path of least regulatory resistance. A pair of pivotal trials is slated to commence in 2017.
Savella's Secret? "Unknown Factor" Could Be Key To Symptom Relief
The effect of Forest’s fibromyalgia therapy Savella (milnacipran) on a composite responder endpoint in Phase III did not correspond to the results for individual components of that endpoint, an "unusual finding" that the reviewing FDA division director suggested could result from the drug’s effect on an "unknown factor."
Savella's Secret? "Unknown Factor" Could Be Key To Symptom Relief
The effect of Forest’s fibromyalgia therapy Savella (milnacipran) on a composite responder endpoint in Phase III did not correspond to the results for individual components of that endpoint, an "unusual finding" that the reviewing FDA division director suggested could result from the drug’s effect on an "unknown factor."