Merck's Propecia(TM) Cleared For Marketing: Once-A-Day Pill Offers Men Effective Treatment For Male Pattern Hair Loss
WEST POINT, Pa., Dec. 22 /PRNewswire/ -- New hope is on the horizon today for millions of American men who are concerned about losing their hair, and who believe there is little they can do about it. Merck & Co., Inc. (NYSE: MRK - news) announced that the U.S. Food and Drug Administration has granted marketing clearance to Propecia(TM) (finasteride 1 mg), the first and only pill to treat male pattern hair loss (androgenetic alopecia), for use in men only. Propecia (pronounced pro-PEE-sha) will be available by prescription only and should be on pharmacy shelves by mid-January.
The marketing clearance of Propecia is based on data from three one-year, double-blind, placebo-controlled, multicenter clinical trials involving 1,879 men aged 18 to 41 with mild to moderate hair loss of the vertex and anterior mid-scalp areas. In addition, 1,215 of the men who had hair loss at the vertex, or top of the head, were studied for another year.
Hair count increased during the first year and was maintained in those men taking Propecia for 24 months; men in the placebo group continued to show progressive hair loss. In an analysis of the men who were followed for up to two years, only 17 percent of men treated with Propecia demonstrated hair loss (defined as any decrease in hair count from baseline); 83 percent had the same or higher hair count. In contrast, 72 percent of the placebo group lost hair, as measured by hair count. Through questionnaires, all patients were asked to evaluate their response to treatment. Those on Propecia reported an increase in the amount of hair, a decrease in hair loss, and improvement in appearance. Clinical improvement was seen as early as three months.
In another analysis, a panel of independent dermatologists evaluated photos in 508 patients after 24 months of treatment. An increase in hair growth was demonstrated in 66 percent of men treated with Propecia compared to 7 percent of men treated with placebo. Efficacy in bitemporal recession has not been established. All men, whether receiving Propecia or placebo, were given a medicated shampoo (Neutrogena T/Gel Shampoo).
''Propecia works by inhibiting the conversion of testosterone to DHT (dihydro-testosterone),'' said Keith Kaufman, M.D., senior director, Clinical Research, Merck Research Laboratories in Rahway, N.J. ''It is the first treatment to target this key factor in the development of androgenetic alopecia in those patients genetically predisposed.''
Cautionary Information for Women
Propecia is for use by men only. It is not for use in women or children. Women must not use Propecia when they are or may potentially be pregnant because it may cause abnormalities of the male baby's sex organs, a condition known as hypospadias. In addition, women should not handle crushed or broken tablets when they are pregnant or may potentially be pregnant. Propecia tablets have a coating that will prevent contact with the active ingredient during normal handling, provided that the tablets have not been broken or crushed.
Side Effects: Uncommon
In clinical studies, side effects were uncommon and did not affect most men. A small number of men reported less desire for sex, difficulty in achieving an erection and/or a decrease in the amount of semen. Each of these effects occurred in less than 2 percent of men. These side effects went away in all men who discontinued therapy because of them and also disappeared in 58 percent of men who chose to continue taking Propecia.
Merck's catalog price to wholesalers and direct purchasers for Propecia will be $1.25 per tablet. Merck estimates that the retail price for Propecia will be between $45 to $49 per month, based on historical markups at the retail level. Prices at the retail level are established by pharmacies, not by Merck, and can vary. Propecia will be available in bottles of 30 and in special ProPak(TM) convenience packages that feature a three-month supply, a $10 patient rebate and an informational patient brochure.
Merck & Co., Inc. is a leading research-driven pharmaceutical products and services company. Merck discovers, develops and markets a broad range of innovative products to improve human health and quality of life.
Neutrogena T/Gel is a registered trademark of Johnson & Johnson
The patient package insert for Propecia is attached. Full prescribing information is available by calling 800-753-0352, ext. 702.
PROPECIA
(Finasteride) Tablets
Patient Information about PROPECIA (Pro-pee-sha)
Generic name: finasteride (fin-AS-tur-eyed)
PROPECIA is for use by MEN ONLY.
Please read this leaflet before you start taking PROPECIA. Also, read the information included with PROPECIA each time you renew your prescription, just in case anything has changed. Remember, this leaflet does not take the place of careful discussions with your doctor. You and your doctor should discuss PROPECIA when you start taking your medication and at regular checkups.
What is PROPECIA used for?
PROPECIA is used for the treatment of male pattern hair loss on the vertex and the anterior mid-scalp area.
PROPECIA is for use by MEN ONLY and should NOT be used by women or children.
What is male pattern hair loss?
Male pattern hair loss is a common condition in which men experience thinning of the hair on the scalp. Often, this results in a receding hairline and/or balding on the top of the head. These changes typically begin gradually in men in their 20s.
Doctors believe male pattern hair loss is due to heredity and is dependent on hormonal effects. Doctors refer to this type of hair loss as androgenetic alopecia.
Results of clinical studies:
-- For 12 months, doctors studied over 1800 men aged 18 to 41 with mild to moderate amounts of ongoing hair loss. All men, whether receiving PROPECIA or placebo (a pill containing no medication) were given a medicated shampoo (Neutrogena T/Gel(R)1 Shampoo). Of these men, approximately 1200 with hair loss at the top of the head were studied for an additional 12 months. In general, men who took PROPECIA maintained or increased the number of visible scalp hairs and noticed improvement in their hair in the first year, with the effect maintained in the second year. Hair counts in men who did not take PROPECIA continued to decrease.
In one study, patients were questioned on the growth of body hair. PROPECIA did not appear to affect hair in places other than the scalp.
Will PROPECIA work for me?
For most men, PROPECIA increases the number of scalp hairs, helping to fill in thin or balding areas of the scalp. Men taking PROPECIA noted a slowing of hair loss during two years of use. Although results will vary, generally you will not be able to grow back all of the hair you have lost. There is not sufficient evidence that PROPECIA works in the treatment of receding hairline in the temporal area on both sides of the head.
Male pattern hair loss occurs gradually over time. On average, healthy hair grows only about half an inch each month. Therefore, it will take time to see any effect.
You may need to take PROPECIA daily for three months or more before you see a benefit from taking PROPECIA. PROPECIA can only work over the long term if you continue taking it. If the drug has not worked for you in twelve months, further treatment is unlikely to be of benefit. If you stop taking PROPECIA, you will likely lose the hair you have gained within 12 months of stopping treatment. You should discuss this with your doctor.
How should I take PROPECIA?
Follow your doctor's instructions.
Take one tablet by mouth each day.
You may take PROPECIA with or without food.
If you forget to take PROPECIA, do not take an extra tablet. Just take
the next tablet as usual.
PROPECIA will not work faster or better if you take it more than once a day.
Who should NOT take PROPECIA?
-- PROPECIA is for the treatment of male pattern hair loss in MEN ONLY and
should not be taken by women or children.
-- Anyone allergic to any of the ingredients.
A warning about PROPECIA and pregnancy.
-- Women who are or may potentially be pregnant:
- must not use PROPECIA
- should not handle crushed or broken tablets of PROPECIA.
If a women who is pregnant with a male baby absorbs the active ingredient in PROPECIA, either by swallowing or through the skin, it may cause abnormalities of a male baby's sex organs. If a woman who is pregnant comes into contact with the active ingredient in PROPECIA, a doctor should be consulted. PROPECIA tablets are coated and will prevent contact with the active ingredient during normal handling, provided that the tablets are not broken or crushed.
What are the possible side effects of PROPECIA?
Like all prescription products, PROPECIA may cause side effects. In clinical studies, side effects from PROPECIA were uncommon and did not affect most men. A small number of men experienced certain sexual side effects. These men reported one or more of the following: less desire for sex; difficulty in achieving an erection; and, a decrease in the amount of semen. Each of these side effects occurred in less than 2% of men. These side effects went away in men who stopped taking PROPECIA. They also disappeared in most men who continued taking PROPECIA.
The active ingredient in PROPECIA is also used by older men at a five- times higher dose to treat enlargement of the prostate. Some of these men reported other side effects, including problems with ejaculation, breast swelling and/or tenderness and allergic reactions such as lip swelling and rash. In clinical studies with PROPECIA, these side effects occurred as often in men taking placebo as in those taking PROPECIA.
Tell your doctor promptly about these or any other unusual effects.
PROPECIA can effect a blood test called PSA (Prostate-Specific Antigen) for the screening of prostate cancer. If you have a PSA test done, you should tell your doctor that you are taking PROPECIA.
Storage and handling.
Keep PROPECIA in the original container and keep the container closed. Store it in a dry place at room temperature. PROPECIA tablets are coated and will prevent contact with the active ingredient during normal handling, provided that the tablets are not broken or crushed.
Do not give your PROPECIA tablets to anyone else. It has been prescribed only for you. Keep PROPECIA and all medications out of the reach of children.
THIS LEAFLET PROVIDES A SUMMARY OF INFORMATION ABOUT PROPECIA. If after reading this leaflet you have any questions or are not sure about anything, ask your doctor.
1-800-830-7375, Monday through Friday, 8:30 A.M. TO 7:00 P.M. (ET). |
