May 18, 2011 01:03 PM Eastern Daylight Time 

HONOLULU–(EON: Enhanced Online News)–Results were reported today in a multi-center, randomized, placebo-controlled clinical study of adding Deplin® (15 mg L-methylfolate) compared to adding placebo in patients with major depressive disorder with an inadequate response to common antidepressants known as selective serotonin reuptake inhibitors (SSRIs). Adjunctive clinical dietary management with Deplin® 15 mg significantly improved the benefits of the antidepressant therapy compared to continued antidepressant monotherapy.

According to the landmark Sequenced Treatment Alternatives to Relieve Depression (STAR*D) study, nearly 70 percent of patients treated with initial monotherapy will fail to achieve remission of their major depression.1 Depression, a chronic, recurrent disease, is one of the nation’s most common ailments, affecting more than 18 million people in the United States.2

The 223 patient study was presented today at an oral scientific report at the American Psychiatric Association Annual Meeting. this study validates the body of evidence supporting metabolic management with L-methylfolate, a medical food, administered in combination with antidepressants.3,4

Outcomes

two primary outcome measures were used in the study: Rates of response (50 percent reduction) in the 17-question Hamilton Depression Rating Scale (HDRS-17) and degree of improvement (mean change) in HDRS-17.

The data showed significantly higher response rates (50% reduction in HDRS-17) after 30 days in patients who received adjunctive Deplin® 15 mg with an SSRI compared to patients who received SSRI and adjunctive placebo. There was also a significantly greater reduction in depressive symptoms as measured by mean change in HDRS-17 in the adjuvant Deplin® 15 mg arm compared to the adjuvant placebo arm.

Before beginning the study, all patients had to demonstrate inadequate response to one or two SSRIs. Antidepressants included in the randomized trial were therapeutic doses of fluoxetine, citalopram, paroxetine, escitalopram, and sertraline. once the patients entered into the study, the SSRI doses remained constant. There was no significant difference in side effects reported with adjunctive Deplin® 15 mg. Rates of discontinuation due to adverse events were no different in the Deplin® 15 mg and SSRI group compared to the placebo and SSRI group.

Additional Findings

Secondary outcomes measures included changes in scores on the self-rated Quick Inventory of Depressive Symptomatology (QIDS-SR) and the Clinical Global Impression Severity Scale (CGI-S). both of these measures showed significantly greater efficacy in favor of the Deplin® with SSRI group.

About the Study

The two trials in this study used a novel sequential parallel comparison design (or SPCD). Results from the first of two trials (n = 148) was used to inform the dosing of the second trial (n = 75). The first trial found 7.5 mg dosing of L-methylfolate and an SSRI was not significantly different in efficacy compared to placebo and SSRI. The second trial found 15 mg dosing L-methylfolate and an SSRI was significantly superior on response rates and degree of improvement in depressive symptoms compared to placebo and SSRI.

Folate Deficiency & L-Methylfolate

Scientists have long suspected an association between a deficiency in the bioactive form of folate and depression, and studies have been conducted to determine if the active form of folate can improve depression symptoms.3,4,5,6,7 Up to 70 percent of people who suffer from depression may have a specific genetic factor that compromises their ability to convert folate from food or synthetic folic acid into the bioactive form, L-methylfolate.

L-methylfolate has been categorized as a Trimonoamine Modulator (TMM) because it is the only form of folate that can cross the blood-brain barrier to help regulate serotonin, norepinephrine and dopamine, the neurotransmitters associated with mood.8 in this first randomized, placebo controlled study, L-methylfolate was chosen because of its ability to cross the blood brain barrier, its bioavailability and safety benefits compared to folic acid and other synthetic folates.

About Deplin®

Deplin® is a prescription medical food for the clinical dietary management of the metabolic imbalances associated with depression. Use under medical supervision.9

for more information visit deplin.comor see full prescribing information.

1 Trivedi M, rush a, Wisniewski S, et al. Evaluation of Outcomes with Citalopram for Depression Using Measurement-Based Care in STAR*D: Implications for Clinical Practice. am J Psychiatry. 2006;163:28-40.

2 The National Institute of Mental Health (NIMH). (n.d.). The Numbers Count: Mental Disorders in America. Retrieved from: nimh.nih.gove/health/publications/the-numbers-count-mental-disorders-in-america/index.shtml.

3 Ginsberg LD, Oubre a, Daoud Y. L-methylfolate plus SSRI or SNRI from Treatment Initiation Compared to SSRI or SNRI Monotherapy in a Major Depressive Episode. Innov Clin Neurosci. 2011;8(1):19-28.

4 Godfrey P, Crellin R, Toone BK, et al. Enhancement of recovery from psychiatric illness by methylfolate. Br J Psychiatry. 1992;161:126-7.

5 DiPalma C et al. Is Methylfolate Effective in Relieving Major Depression in Chronic Alcoholics? a Hypothesis of Treatment. Curr Ther Res. 1994;55(5):559-68.

6 Guaraldi et al. a Open Trial of Methyltetrahydrofolate in Elderly Depressed Patients. Annals Clin Psych. 1993;5(2):101-5.

7 Passeri M et al. ‘Oral 5’-Methyltetrahydrofolic Acid in Senile Organic Mental Disorders with Depression: Results of a Double-blind Multicenter Study. Aging Clin Exp Res. 1993;5(1):63-71.

8 Stahl SM. Novel Therapeutics for Depression: L-methylfolate as a Trimonoamine Modulator and Antidepressant Augmenting Agent. CNS Spectrums. 2007;12(10):739-44.

9 Deplin® Package Insert. Pamlab, L.L.C. 04/2011.

Pfizer Inc. (NYSE:PFE) today announced that the ORAL Sync Phase 3 study (A3921046) of tofacitinib (development code: CP-690,550), formerly known as tasocitinib, an investigational, novel, oral JAK inhibitor, being studied in moderate-to-severe rheumatoid arthritis (RA), met its primary endpoints by showing statistically significant changes versus placebo in reducing signs and symptoms of RA, as measured by ACR20 response rates at six months; in improving physical function, as measured by mean change in HAQ DI at three months; and in reaching DAS28-4(ESR) <2.6 at six months. The safety profile of tofacitinib was consistent with that seen previously in the clinical program, and no new safety signal was detected. a full analysis of efficacy and safety data will be submitted to a future scientific meeting.

About ORAL Sync

ORAL Sync evaluated the efficacy and safety of tofacitinib doses 5 mg and 10 mg given twice daily compared to placebo in patients with moderately to severely active RA who had a previous inadequate response to a DMARD and who continued to receive background traditional DMARD therapy throughout the study.

About Rheumatoid Arthritis

Rheumatoid arthritis is a chronic inflammatory autoimmune disease that typically affects the hands and feet, although any joint lined by a synovial membrane may be affected. RA affects approximately 1.3 million people in the U.S. 1 and 1 percent of the adult population worldwide.2

About Tofacitinib

Tofacitinib is a novel, oral Janus kinase (JAK) inhibitor that is being investigated as a targeted immunomodulator and disease-modifying therapy for RA. More than 4,000 RA patients have been treated with tofacitinib in clinical trials to date. unlike current therapies for RA, which are directed at extracellular targets such as pro-inflammatory cytokines, tofacitinib takes a novel approach, targeting the intracellular signaling pathways that operate as hubs in the inflammatory cytokine network.

The Phase 3 ORAL Trials clinical program includes six studies with more than 350 locations in 35 countries worldwide. For more information, visit ORALtrials.com.

Pfizer is also studying orally administered tofacitinib in psoriasis, inflammatory bowel disease (Crohn’s disease and ulcerative colitis) and renal transplant, and topical tofacitinib in both psoriasis and dry eye disease.

Pfizer Inc.: Working together for a healthier world?

at Pfizer, we apply science and our global resources to improve health and well-being at every stage of life. We strive to set the standard for quality, safety and value in the discovery, development and manufacturing of medicines for people and animals. Our diversified global health care portfolio includes human and animal biologic and small molecule medicines and vaccines, as well as nutritional products and many of the world’s best-known consumer products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as the world’s leading biopharmaceutical company, we also collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us. to learn more about our commitments, please visit us at pfizer.com.

DISCLOSURE NOTICE: The information contained in this release is as of March 4, 2011. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

this release contains forward-looking information about a product in development, tofacitinib, including its potential benefits as a treatment for rheumatoid arthritis, certain other diseases and renal transplant, that involves substantial risks and uncertainties. Such risks and uncertainties include, among other things, the uncertainties inherent in research and development; decisions by regulatory authorities regarding whether and when to approve any drug applications that may be filed for tofacitinib as well as their decisions regarding labeling and other matters that could affect its availability or commercial potential; and competitive developments.

a further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2010 and in its reports on Form 10-Q and Form 8-K.

1 Arthritis Today. ?What is Rheumatoid Arthritis.? Accessed 24 February 2011. available at: arthritistoday.org/conditions/rheumatoid-arthritis/all-about-ra/what-is-ra.php.2 Rubbert-Roth a, Finckh a. Treatment options in patients with rheumatoid arthritis failing initial TNF inhibitor therapy: a critical review. Arthritis Res Ther. 2009; 11(Suppl 1): S1.Published online 2009 April 6. doi: 10.1186/ar2662.

Pfizer Inc.Media:Victoria Davis, 484-865-5194M: Investors:Jennifer Davis,