Updated Clinical Trial Notes on Somaxon, Theravance

1.) Somaxon (SOMX) Silenor (doxepin) NDA - Filed under 505(b) Pathway - New Indication for an Approved, Generically Available Drug. Somaxon's new formulation of doxepin is at lower doses (1, 3, 6 mg) compared to existing generic products on the market at doses of 10mg-150mg to reduce the incidence of side effects - Complete Response Letter from FDA on 2/26/09 related to interpretation of efficacy data in the Silenor NDA - pending discussion with FDA to clarify next steps

2.) Theravance (THRX) Complete Response Letter (CRL) from FDA on 2/26/09 for telavancin in the treatment of complicated skin and skin structure infections (cSSSI). Telavancin is a once-daily injectable (IV) antibiotic for cSSSI and hospital-acquired pneumonia (HAP) caused by Gram-positive bacteria, including resistant pathogens such as methicillin-resistant Staphylococcus aureus (MRSA). CRL requires a Risk Evaluation and Mitigation Strategy (REMS), data on patients with certain renal risk factors from the cSSSI and HAP studies, revisions to the draft label, and a safety update.

The REMS will consist of a Medication Guide, a communications plan and a timetable for submission of assessments to ensure the benefits of the drug outweigh the risk of potential teratogenicity. A boxed warning related to this risk will be included in the package insert noting that females of childbearing potential should have a negative pregnancy test prior to administration. A post-approval registry of pregnant women exposed to telavancin will also be required. The letter indicates that telavancin, if approved, will be classified as pregnancy category C. The HAP data can be provided by cross reference to the recently submitted New Drug Application (NDA). The required revisions to the draft labeling include monitoring of renal function and cautionary language regarding the use of telavancin in patients with certain renal risk factors.