Navigation Links
Lilly Announces Edivoxetine Did Not Meet Primary Endpoint of Phase III Clinical Studies as Add-On Therapy for Major Depressive Disorder

INDIANAPOLIS, Dec. 5, 2013 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today that results from three studies of edivoxetine did not meet the primary study objective of superior efficacy in depression after eight weeks of treatment. When added to a selective serotonin reuptake inhibitor (SSRI), edivoxetine did not separate from placebo on the Montgomery-Asberg Depression Rating Scale (MADRS) in three acute randomized placebo-controlled Phase III studies (LNBM, LNBQ and LNBR).

While the safety and tolerability of edivoxetine was consistent with previous studies, the efficacy results do not support a regulatory submission for adjunctive treatment in patients with Major Depressive Disorder (MDD). Data from all three studies will be disclosed in appropriate scientific forums in 2014.

In 2010, Lilly launched the Phase III program for edivoxetine – a potent and highly selective norepinephrine reuptake inhibitor – to assess the benefits and risks of edivoxetine as an add-on therapy in patients with MDD.  The Phase III program specifically focused on meeting the unmet needs of patients with major depression who had achieved only a partial response to treatment with an SSRI.  In these three trials, patients remained on SSRI treatment and additionally received either edivoxetine or placebo. 

"Lilly undertook a robust Phase III program to address a significant unmet need for people suffering from depression," said David Ricks, senior vice president, and president, Lilly Bio-Medicines. "However, the lack of efficacy compared to SSRI alone in three separate clinical trials means that Lilly will not proceed with development of edivoxetine as an add-on treatment for depression." The ongoing clinical study evaluating the long-term maintenance effect of edivoxetine will continue to completion.

"While disappointing for people suffering from depression, their families and Lilly, negative studies are unfortunately a reality of biopharmaceutical innovation, and are particularly prevalent in the area of neuroscience given the historically high placebo response rate," said Jan Lundberg, Ph.D., executive vice president, science and technology, and president, Lilly Research Laboratories. "Lilly remains committed to our neuroscience legacy of discovering and delivering innovative medicines, as evidenced by our pipeline of nine potential new medicines and diagnostic imaging agents for neuroscience-related diseases and disorders, including Alzheimer's disease, Parkinson's disease, depression, bipolar disorder, migraine prevention and osteoarthritis pain."

"Despite this news, we remain focused on implementing our innovation-based strategy," said Derica Rice, executive vice president, global services and chief financial officer, Eli Lilly and Company.  "We've made substantial progress on our number one priority - advancing our pipeline.  This year alone, we submitted four potential new medicines to regulatory authorities with more anticipated next year.  In addition, we expect to begin launching new products in 2014 and are on track to return to revenue growth and margin expansion in 2015 and beyond."

The decision not to proceed with development of edivoxetine as adjunctive treatment for MDD is expected to result in a fourth-quarter charge to R&D expense of approximately $15 million (pre-tax), or approximately $0.01 per share (after-tax). The company's previously-issued financial guidance for 2013 remains unchanged.

About Eli Lilly and Company
Lilly, a leading innovation-driven corporation, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers – through medicines and information – for some of the world's most urgent medical needs. Additional information about Lilly is available at  

This press release contains forward-looking statements about edivoxetine and reflects Lilly's current beliefs. As with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. For further discussion of these and other risks and uncertainties, see Lilly's filings with the United States Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements.

P-LLY Refer to:(317) 651-5567 –

Morry Smulevitz, Lilly Bio-Medicines (317) 655-6874 –

Phil Johnson, Investor Relations

SOURCE Eli Lilly and Company
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Zacks Industry Outlook Highlights: Merck, Pfizer, Forest Laboratories, Sanofi and Eli Lilly
2. Largest Global Survey Investigating Early Type 2 Diabetes Conversations Launched by Boehringer Ingelheim and Eli Lilly and Company in Partnership with the International Diabetes Federation
3. Surveyed Endocrinologists Consider Eli Lillys Dulaglutide To Have an Edge Over Competitors for the Treatment of Type 2 Diabetes Patients Who Are Inadequately Controlled On Metformin
4. Lilly Statement on Contribution to Indiana Biosciences Research Institute
5. Lilly Announces Significant Global Insulin Manufacturing Capacity Investments in Response to Growing Diabetes Epidemic
6. Medtronic, Lilly Diabetes Join Together as First Ever National Presenting Sponsors of the JDRF Walk To Cure Diabetes
7. Lilly announces Tapiero retiring; Zulueta promoted to senior vice president and president of Emerging Markets
8. Lilly Reports Third-Quarter 2013 Results
9. FDA Grants Lillys Ramucirumab Priority Review as a Potential Single-Agent Treatment for Advanced Gastric Cancer
10. Lilly Declares Fourth-Quarter 2013 Dividend
11. Lilly Reintegration Scholarship Applications Available for 2014-2015 Academic Year
Post Your Comments:
(Date:6/23/2016)... 23, 2016  In a startling report released today, National ... by lacking a comprehensive, proven plan to eliminate prescription opioid overdoses. ... of how states are tackling the worst drug crisis in recorded ... – Kentucky , New Mexico ... . Of the 28 failing states, three – Michigan ...
(Date:6/23/2016)... June 23, 2016 Research and Markets ... Issue 52" report to their offering. ... treatment creates a favourable commercial environment for MedImmune to enter. ... base that will serve to drive considerable growth for effective ... serve to cap sales considerably, but development is still in ...
(Date:6/23/2016)... the establishment of Astellas Farma Colombia (AFC), a new affiliate with operations headquartered in Bogota. Colombia ... ... Sandra ... ... Astellas is a pharmaceutical company ...
Breaking Medicine Technology:
(Date:6/27/2016)... Aliso Viejo, California (PRWEB) , ... June 27, 2016 , ... ... that are fully customizable inside of Final Cut Pro X," said Christina Austin - ... with another unique style. Final Cut Pro X users can now reveal ...
(Date:6/27/2016)... Park, KS (PRWEB) , ... June 27, 2016 , ... ... in retailers of Eyeglasses . , Millions of individuals in the United States ... eyeglasses have become a way to both correct vision and make a fashion statement. ...
(Date:6/26/2016)... ... June 26, 2016 , ... PawPaws brand pet supplements owned by ... to enhance the health of felines. The formula is all-natural and is made from ... the PawPaws Cat Kidney Support Supplement Soft Chews are Astragalus Root Extract ...
(Date:6/25/2016)... ... June 25, 2016 , ... Austin residents seeking Mohs surgery services, ... Mohs Surgery and to Dr. Russell Peckham for medical and surgical dermatology. , Dr. ... skin cancer. The selective fellowship in Mohs Micrographic Surgery completed by Dr. Dorsey was ...
(Date:6/25/2016)... ... June 25, 2016 , ... As a lifelong Southern Californian, ... and his M.D from the David Geffen School of Medicine at UCLA. He trained ... Angeles to complete his fellowship in hematology/oncology at the UCLA-Olive View-Cedars Sinai program where ...
Breaking Medicine News(10 mins):