Salix Pharmaceuticals announced Monday that federal regulators have signaled they will approve its drug Relistor for treatment of chronic pain in non-cancer patients.
The Food and Drug Administration is requiring some post-marketing observational studies, but will not require Salix and its partner Progenics Pharmaceuticals to submit additional data as part of its new drug application.
Salix expects to submit the additional information requested by the FDA within the next several weeks.
The FDA’s approval is for an injectable version of Relistor. Sterne Agee analyst Shibani Maholtra said in a note Monday that a future oral formulation of the drug is where the real value is likely to be. An approved oral formulation of Relistor could lead to $500 million to $750 million in annual sales, she estimated.
Salix shares were up about 2 percent in mid-morning trading Monday.