DOW JONES NEWSWIRES
A nonprofit group urged the Food and Drug Administration to take
the fibromyalgia drug Savella off the market immediately, saying
its dangers outweigh its benefits.
Savella, introduced by Forest Laboratories Inc. (FRX) and
Cypress Bioscience Inc. (CYPB) last spring, "produces only a
marginal effect on pain" but has the potential "to be quite
dangerous," Public Citizen said in a petition Wednesday.
In Forest's latest quarter, Savella had sales of $15.4 million,
up 50% from the prior quarter. The drug competes with Pfizer Inc.'s
(PFE) Lyrica.
As part of its argument, Public Citizen noted that European
regulators in July rejected Savella, saying its benefits were
"marginal" and "did not outweigh its risks." The FDA approved the
drug a year ago to treat fibromyalgia, a chronic condition
characterized by widespread pain and decreased physical
function.
Public Citizen also highlighted Savella's side effects in its
letter to the FDA. Trials found the drug increased increase blood
pressure, heart rate and suicidal thoughts, the group said. The
rate of those having normal blood pressure at the beginning of the
study and developing hypertension after taking Savella was triple
that of patients which received placebo.
Forest Labs had no immediate comment. Its stock was down 11
cents at $31.66 amid a broad market selloff while Cypress fell 4%
to $5.70.
-By Kathy Shwiff, Dow Jones Newswires; 212-416-2357;
Kathy.Shwiff@dowjones.com