Forest Lexapro “Re-Launch” For Generalized Anxiety Set For Mid-January

Forest will begin promotion of Lexapro for generalized anxiety disorder in mid-January.

FDA approved escitalopram for GAD Dec. 18. The new indication had been "approvable" at FDA since Oct. 6 (¹ 'The Pink Sheet' Oct. 6, 2003, In Brief). Lexapro was already approved for depression.

Forest has high hopes for the label expansion, which it said would prompt a "re-launch" of the drug.

The "re-launch" is slated to begin in mid-January after regional training meetings for Forest's 2,800-person Lexapro sales force, the company said.

Forest plans to focus on professional promotion for GAD. No direct-to-consumer ads are planned for the new indication.

In April, the company identified GlaxoSmithKline's Paxil as the "leading" product among the selective serotonin reuptake inhibitors in the GAD market, but noted that Lexapro already held about a 7% share despite not having a labeled claim (² (Also see "Forest Expects Lexapro To Lead Market By ’05; Will Re-Launch In GAD In ’04" - Pink Sheet, 28 Apr, 2003.), p. 35).

GSK is no longer actively promoting Paxil after the launch of generic versions of the drug during 2003. GSK's follow on Paxil CR is not indicated for GAD.

Forest expects Lexapro to lead the SSRI market by 2005, with one source of growth being the "over $4 bil." anxiety disorders market. A filing for social anxiety disorder is expected in early 2004, and a panic disorder indication is pending at FDA. Forest said it expects an "approvable" letter for panic by spring 2004.

Outside the SSRI category, Lexapro will compete with Wyeth's Effexor XR (venlafaxine), which was approved for GAD in 1999.

A warning on suicidality in pediatric patients was added to Effexor labeling this summer (³ (Also see "Wyeth Effexor Label Revised With Suicide-Related Adverse Events Precaution" - Pink Sheet, 8 Sep, 2003.), p. 6).

FDA subsequently issued a warning on the potential for suicidal behavior in children taking several other antidepressants, including Forest's Celexa (citalopram) (⁴ (Also see "FDA Expands Pediatric Suicidality Caution To Antidepressants Beyond Paxil" - Pink Sheet, 3 Nov, 2003.), p. 11). ⁵ Lexapro labeling states that "safety and effectiveness in pediatric patients have not been established."