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THRX > SEC Filings for THRX > Form 8-K on 13-Nov-2013All Recent SEC Filings

Show all filings for THERAVANCE INC



Regulation FD Disclosure

Item 7.01 Regulation FD Disclosure.

The information contained in this Item 7.01 shall not be deemed filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Securities Exchange Act of 1934"), or incorporated by reference in any filing under the Exchange Act or the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such filing.

Today Rick E Winningham, Chief Executive Officer of Theravance, Inc. (the "Company") presented at the 2013 Credit Suisse Annual Health Care Conference in Scottsdale, Arizona. During the slide presentation, Mr. Winningham announced that TD-9855 did not meet the primary efficacy endpoint of symptom reduction as measured by AISRS (Adult Investigator Symptom Rating Scale) total score versus placebo in the Phase 2 study in adult patients with Attention-Deficit/Hyperactivity Disorder (ADHD). TD-9855 was generally well tolerated with no serious adverse events at either the 5 mg or 20 mg dose of TD-9855. The most frequent adverse events observed in the study were headache, dizziness, decreased appetite, fatigue, and dry mouth. Mr. Winningham announced that the Company will not be continuing its TD-9855 program in ADHD. TD-9855 is currently being evaluated in an ongoing Phase 2 study in patients with fibromyalgia. Results from the fibromyalgia Phase 2 study are anticipated during the first half of 2014. TD-9855 is an investigational norepinephrine and serotonin reuptake inhibitor for the treatment of central nervous system conditions such as chronic pain.

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