GlaxoSmithKline going for Avodart hair loss approval??

Submitted by Regrowth.com Webmaster on Tue, Jul 20, 2010.

Recently released Phase III study for hair loss raises questions about approval strategy for hair loss.

Avodart for Hair Loss Until today I thought Avodart would never be approved for hair loss.

The company that makes it, GlaxoSmithKline, ended US approval studies with no specified reason, but most in the know believe it was due to expected cost and the sales potential not being high enough (possibly due to the cost).

Now, however, comes news of phase III studies of the currently approved 0.5mg dosage for hair loss - not from the US but from Korea. The studies give us some answers and some questions about Avodart.

The question really is what GSK's strategy is going forward. It appears they will now try to get the currently marketed dose approved for hair loss. Are they just going to try getting it approved in Korea or a few other markets? Will they try for US approval? Do they ever intend to pursue the 2.5mg dose? We will be attempting to contact GSK to find out what they are willing to admit regarding their approval strategy going forward for Avodart for hair loss.

This study should put a lot of men who are taking the 0.5mg dosage more at ease. Many are using 0.5mg 'off-label' for hair loss, since it reduces DHT greater than finaseride -- but the 2.5mg dose was the dose studied for hair loss previously, not 0.5mg. Now finally those people using Avodart 0.5mg for hair loss can have some idea what to expect.

The results? Men on Avodart 0.5mg grew 12.4 hairs per square centimeter compared to 4.7 per square centimeter for placebo and "significantly higher" effect compared to placebo based on patient self evaluation, investegator and photographic assessment.

The study was only for 6 months, so it is likely had it gone to 12 months, the results would have been even better. We have obtained the full study details and will be posting more infromation soon.

Study information is below.

Efficacy, safety, and tolerability of dutasteride 0.5 mg once daily in male patients with male pattern hair loss: A randomized, double-blind, placebo-controlled, phase III study.

J Am Acad Dermatol. 2010 Aug;63(2):252-258. Epub 2010 Jun 3.
Eun HC, Kwon OS, Yeon JH, Shin HS, Kim BY, Ro BI, Cho HK, Sim WY, Lew BL, Lee WS, Park HY, Hong SP, Ji JH.Department of Dermatology, Seoul National University College of Medicine, Seoul, Korea

BACKGROUND: Dutasteride (Avodart) is a dual inhibitor of both type I and type II 5 alpha reductases, and thus inhibits conversion of testosterone to dihydrotestosterone, a key mediator of male pattern hair loss.

OBJECTIVES: The aim of this randomized double-blind phase III study was to compare the efficacy, safety, and tolerability of dutasteride (0.5 mg) and placebo for 6 months of treatment in male patients with male pattern hair loss.

METHODS: A total of 153 men, 18 to 49 years old, were randomized to receive 0.5 mg of dutasteride or placebo daily for 6 months. Efficacy was evaluated by the change of hair counts, subject assessment, and photographic assessment by investigators and panels.

RESULTS: Mean change of hair counts from baseline to 6 months after treatment start was an increase of 12.2/cm(2) in dutasteride group and 4.7/cm(2) in placebo group and this difference was statistically significant (P = .0319). Dutasteride showed significantly higher efficacy than placebo group by subject self-assessment and by investigator and panel photographic assessment. There was no major difference in adverse events between two groups.

LIMITATIONS: The study was limited to 6 months.

CONCLUSIONS: This study clearly showed that 0.5 mg of dutasteride improved hair growth and was relatively well tolerated for the treatment of male pattern hair loss.

MEMBER COMMENTS ON THIS ARTICLE

Zixcreator

It would have been nice if we had some data in this study related to the benefits of Avodart over Propecia. Data that would clearly show which one is truly better.

JohnNYC

I can't imagine why it would not be better as adjunct therapy. There problem is that any antiandrogens alone have never been should to be effective alone, as castration and radical prostatectomy does not restore hair in bald men.

Regrowth.com Webmaster
Norwood 3v

The basic science shows it's clearly better at DHT reduction. There's really no way Finasteride can be better. The only question is whether Avodart is much better at growing more hair for more people or whether they're about the same. My guess is it is probably a little better, but not dramatically - and probably will stop hair loss for more men than Propecia.

"Don't be afraid to see what you see. "

JohnNYC

The problem is even castration does not cause hair regrowth.

Izabella

Drug-maker <a title="Lawsuit states that Parkinson's drug made him a homosexual sex addict" href="http://personalmoneystore.com/moneyblog/2011/02/01/french-man-requip-sex-addict/"> GlaxoSmithKline</a> has been named as the defendant in a lawsuit filed on Tues. The 51-year-old male says that Requip, a Parkinson’s drug, changed his character. Effects cited within the legal action include a change in sexual orientation, an addiction to gambling and a sex addition.

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Izabella said:
Drug-maker <a title="Lawsuit states that Parkinson's drug made him a homosexual sex addict" href="http://personalmoneystore.com/moneyblog/2011/02/01/french-man-requip-sex-addict/"> GlaxoSmithKline</a> has been named as the defendant in a lawsuit filed on Tues. The 51-year-old male says that Requip, a Parkinson’s drug, changed his character. Effects cited within the legal action include a change in sexual orientation, an addiction to gambling and a sex addition.

If I am gay would this stuff make me straight?

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John...lol

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