Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

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."

Related Content

Topics

UsernamePublicRestriction

Register

ID036688

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel