Navigation Links
FDA Approves GlaxoSmithKline's AVODART(R) in Combination with Tamsulosin for the Treatment of Symptomatic Enlarged Prostate

PHILADELPHIA, June 19 /PRNewswire-FirstCall/ -- GlaxoSmithKline (NYSE: GSK) today announced that the U.S. Food and Drug Administration (FDA) has approved AVODART (dutasteride) in combination with tamsulosin for the treatment of symptomatic enlarged prostate, a disease that affects half of all men over 50 years old. The new indication reflects emerging research showing the combination of the two medicines treats the symptoms of enlarged prostate more effectively than either medicine alone.

"The combination of AVODART and tamsulosin at diagnosis allows doctors to simultaneously treat the patient's prostate on two fronts by reducing prostate size and rapidly improving symptoms," said Steven A. Kaplan, M.D., from Weill Cornell Medical College of Cornell University in New York City.

Common symptoms of enlarged prostate include nocturia, frequent and urgent urination, incomplete emptying, starting and stopping, and weak stream. If left untreated, enlarged prostate can lead to hospitalization for the inability to urinate or prostate surgery.

AVODART already had been approved by the FDA for the treatment of enlarged prostate to improve urinary symptoms, reduce the risk of acute urinary retention (AUR), and reduce the risk of prostate-related surgery. Tamsulosin, an alpha-blocker, already had been indicated for the treatment of the signs and symptoms of enlarged prostate.

The FDA approval was based on two-year results of the CombAT (Combination of Avodart and Tamsulosin) study, one of the largest clinical trials to date of men with enlarged prostate. The CombAT study is the first long-term assessment of the combination of AVODART and an alpha-blocker. Study results were first presented in September 2007 at the 29th annual meeting of the Societe Internationale d'Urologie in Paris. The study was published in the February issue of the Journal of Urology.

The CombAT study results showed that combination therapy with AVODART and tamsulosin was superior to both monotherapies at Month 12 and continued to Month 24. The primary endpoint was the change in International Prostate Symptom Score (IPSS) from baseline at Month 24 for combination therapy compared to each medication alone. The most common adverse reactions reported in subjects receiving combination therapy were impotence, decreased libido, breast disorders (including breast enlargement and tenderness), ejaculation disorders, and dizziness.

Data from the remaining 2 years of the CombAT study will provide further information on the pattern of symptoms and long-term outcomes associated with combination therapy vs. AVODART and tamsulosin monotherapies.

About CombAT

CombAT is a multicenter, randomized, double-blind and parallel-group study. Men [aged greater than or equal to 50 years with a prostate volume (PV) greater than or equal to 30 cc, serum prostate-specific antigen (PSA) level 1.5-10 ng/mL, Qmax >5 and less than or equal to 15 mL/sec with a minimum voided volume greater than or equal to 125 mL and International Prostate Symptom Score (IPSS) greater than or equal to 12] with moderate-to-severe enlarged prostate symptoms received placebo for four weeks and were then randomized to receive AVODART 0.5 mg/day and tamsulosin 0.4 mg/day (n=1610), AVODART 0.5 mg/day (n=1623), or tamsulosin 0.4 mg/day (n=1611).


AVODART, the first and only dual 5ARI for the treatment of enlarged prostate, inhibits both the type I and type II isoenzymes responsible for the conversion of testosterone into dihydrotestosterone (DHT). DHT is the primary male hormone responsible for the enlargement of the prostate. AVODART suppresses DHT by 93 percent at 2 years. AVODART is indicated for the treatment of symptomatic enlarged prostate in men with an enlarged prostate to improve symptoms, reduce the risk of acute urinary retention (AUR), and reduce the risk of prostate-related surgery. AVODART is now indicated in combination with the alpha blocker tamsulosin for the treatment of symptomatic enlarged prostate. While some men have fewer problems and symptoms after three months of treatment with AVODART, a treatment period of at least six months is usually necessary to see if AVODART will improve symptoms.

Only a healthcare provider can tell if symptoms are from an enlarged prostate and not a more serious condition such as prostate cancer. Men should see their doctors for regular exams. Children and women who are or may become pregnant should not take AVODART. Women who are or may become pregnant should not handle AVODART. Men treated with AVODART should not donate blood until at least six months after their final dose.

Caution should be used in patients with liver disease. Possible side effects include sexual side effects and breast tenderness and/or swelling. These side effects occur infrequently. For full prescribing information, see

About Enlarged Prostate

Enlarged prostate is a prevalent and progressive disease that affects 50 percent of men over 50 years of age and over 90 percent of men older than age 80.1 An enlarged prostate causes changes in urinary habits because of its location around the urethra. Over time, the prostate can continue to grow and urinary symptoms may worsen as the bladder loses the ability to empty itself. Left untreated, in severe cases, an enlarged prostate can lead to serious long-term problems including acute urinary retention (AUR) and the need for prostate-related surgery, and in rare cases even kidney or bladder damage.

About GlaxoSmithKline

GlaxoSmithKline -- one of the world's leading research-based pharmaceutical and healthcare companies -- is committed to improving the quality of human life by enabling people to do more, feel better and live longer. Company information line: 1-888-825-5249. Website address:

* The International Prostate Symptom Score (IPSS) is a symptom index

for enlarged prostate that was developed and validated by a

multidisciplinary measurement committee of the American Urological

Association (AUA). The symptom index includes questions covering

frequency, nocturia, weak urinary stream, hesitancy, intermittence,

incomplete emptying and urgency.


US Media Inquiries: Rob Perry (919) 483 2839

US Analyst/Investor Inquiries: Frank Murdolo (215) 751 7002

Tom Curry (215) 751 5419

SOURCE GlaxoSmithKline
Copyright©2008 PR Newswire.
All rights reserved

Related biology technology :

1. Arpida Annual General Meeting of Shareholders Approves All Board Proposals
2. FDA Approves MIXJECT(TM), a Convenient, Easy-to-Use Drug Delivery System For Watson Pharmaceuticals TRELSTAR(R) DEPOT and TRELSTAR(R) LA
3. FDA Approves VYVANSE(TM) (lisdexamfetamine dimesylate), the First and Only Once-Daily Prodrug Stimulant to Treat ADHD in Adults
4. Maryland Approves Medicaid Reimbursement for ActiPatch(R)
5. Healthcare Coalition Approves Tools to Improve Patient Safety During Transitions of Care
6. Medicare Approves in Home Sleep Apnea Testing
7. 3SBio Inc. Approves Share Repurchase Program
8. Baxters Board of Directors Approves New Share Repurchase Authorization of $2 Billion
9. FDA Approves PRISTIQ(TM) for the Treatment of Adult Patients with Major Depressive Disorder
10. FDA Approves INTELENCE(TM) (etravirine) for HIV Combination Therapy
11. FDA Approves Additional Dosage Strengths of Shires ADHD Treatment VYVANSE(TM) (lisdexamfetamine dimesylate) Which May Help Physicians Tailor Treatment for Individual Patients
Post Your Comments:
(Date:12/1/2015)... ... , ... Matthew “Tex” VerMilyea, PhD, HCLD, has joined Texas Fertility Center as ... lab procedures as well as continue his research efforts into the emerging technologies of ... New Zealand to bring home a High Complexity Clinical Laboratory Director named Tex,” says ...
(Date:11/30/2015)... ... 30, 2015 , ... Global Stem Cells Group ... the Santiago Marriott. The Global Stem Cells Group GMP facility is equipped with ... qualified medical researchers and practitioners, experienced in administering stem cell protocols using highly ...
(Date:11/30/2015)... 2015 Partnership includes an MPP ... for the u niversity , s ... treatment s cale - up through ... Africa , where licensees based anywhere in the world will have ... --> Africa , where licensees based anywhere in the world ...
(Date:11/30/2015)... Spherix Incorporated (Nasdaq: SPEX ) an ... and monetization of intellectual property, today provided an ... to create shareholder value. Anthony ... on published reports, the total addressable market of ... Spherix will seek to secure fair and reasonable ...
Breaking Biology Technology:
(Date:11/17/2015)... , Nov. 17, 2015  Vigilant Solutions announces ... joined its Board of Directors. --> ... after recently retiring from the partnership at TPG Capital, ... companies with over $140 Billion in revenue.  He founded ... across all the TPG companies, from 1997 to 2013.  ...
(Date:11/12/2015)... Nov. 12, 2015  A golden retriever that stayed ... dystrophy (DMD) has provided a new lead for treating ... the Broad Institute of MIT and Harvard and the ... . Cell, pinpoints a protective ... the disease,s effects. The Boston Children,s lab of ...
(Date:11/11/2015)... --  MedNet Solutions , an innovative SaaS-based eClinical technology company ... to announce that it will be a Sponsor of the ... be held November 17-19 in Hamburg , ... iMedNet , MedNet,s easy-to-use, proven and affordable ... been able to deliver time and cost savings of up ...
Breaking Biology News(10 mins):