Dr.Ronald Trancik - Clinical Research Department of the Consumer Healthcare Division at Pharmacia & Upjohn

Next if you could put up slide C5822-15.  A question as it relates to the response to 5 percent occurring faster than the 2 percent.  These are based on data generated in our 0285 male study.  As I had mentioned in my presentation, we looked at the response at week 8 and compared it to the response at week 16.  As you can see, we had an increase of 30 hairs with respect to patients who were treated with Rogaine 5 percent at week 8, and we had the same level of response for patients treated with 2 percent at week 16, and that forms the basis of our statement that the results are seen sooner.
You can see that based on our primary efficacy endpoints, which included key questions which were part of a comprehensive questionnaire, along with the objective endpoint of nonvellus hair counts, there were statistically significant differences between Rogaine 5 percent and 2 percent.  We were able to clearly demonstrate superiority of Rogaine 5 percent versus Rogaine 2 percent using our primary clinical endpoints.
In addition, we were able to demonstrate a dose response based on hair count results in both of our definitive studies in males, namely protocol 001 and 0285, showing that Rogaine 5 was superior to Rogaine 2 percent with both better than placebo.
Superior efficacy in males then is demonstrated both by magnitude of effect and time to response.  Regarding magnitude of effect, we realized a 46 percent increase in hair counts at week 48 with Rogaine 5 percent as compared to Rogaine 2 percent.
In addition and again using hair count data, we demonstrated that the response to Rogaine 5 percent at week 8 was equivalent to the response achieved with Rogaine 2 percent at week 16, thus demonstrated a more rapid onset of hair growth response.
These results, namely superior efficacy and comparable safety of Rogaine 5 percent to Rogaine 2 percent, led to an approvable letter from the FDA for Rogaine 5 percent as a male-only prescription product.

SHAHLA S. FARR, M.S.
Office of Epidemiology and Biostatistics
Division of Biometrics IV, FDA

To gain approval for this new formulation, the sponsor must show statistical superiority of Rogaine 5 percent to its vehicle and Rogaine 5 percent to Rogaine 2 percent using a two-sided 5 percent significance level.
The focus of this report will be on patients' net gain in hair count based on a 1 centimeter square area at the end of the treatment period on the evaluable population, which my evaluable population consisted of subjects who had completed the study.
Subjects were instructed to apply 1 milliliter of the test solution to the affected areas which would be the vertex, which is the back of the head for males, and the front of the scalp for females.  They were instructed to use this twice daily, 12 hours apart.


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Study M/7415/0001
This was a double blind, single center comparison of 5% Rogaine, 2% Rogaine, and the vehicle in 321 evaluable male patients with androgenetic alopecia; this included 163 patients on 5% Rogaine, 79 on 2% Rogaine, and 79 on the vehicle. Applications were made BID for 32 weeks. The efficacy parameters were 1) nonvellus hair counts within a 1 cm2 area of the vertex of the scalp

1) Hair counts. The mean hair counts and the mean changes from baseline were as follows.

Mean Nonvellus hair count
Week (Wk)5% Rogaine2% Rogaine
Wk  0  106103
Wk 16 142128
Wk 32 145133

Mean Change from baseline
Nonvellus hair counts
Week (Wk)5% Rogaine2% RogaineChange
Wk 16 +36+25+11
Wk 32 +39+30+9

Percent Increse from baseline
Nonvellus hair counts
Week (Wk)5% Rogaine2% RogaineChange
Wk 16 34%24%44%
Wk 32 37%29%30%



Study M/7410/0285
This was a double blind, multicenter comparison of 5% Rogaine, 2% Rogaine, and the vehicle in 352 evaluable male patients with androgenetic alopecia; this included 139 patients on 5% Rogaine, 142 on 2% Rogaine, and 71 on the vehicle. Applications were made BID for 48 weeks. The efficacy parameters were 1) nonvellus hair counts within a 1 cm2 area of the vertex of the scalp

1) Hair counts. The mean hair counts and the mean changes from baseline were as follows.

Mean Nonvellus hair counts
Week (Wk)5% Rogaine2% Rogaine
Wk  0  151144
Wk 16 186174
Wk 32 180166
Wk 48 170157

Mean Change from baseline
Nonvellus hair counts
Week (Wk)5% Rogaine2% RogaineChange
Wk 8? +30
Wk 16 +35+30+5
Wk 32 +29+22+7
Wk 48 +19+13+6

Percent Increse from baseline
Nonvellus hair counts
Week (Wk)5% Rogaine2% RogaineChange
Wk 16 23%21%17%
Wk 32 19%15%32%
Wk 48 13%  9%46%
Dr. Phyllis A. Huene, M.D. - FDA Medical Officer
Summary of clinical effectiveness studies
The clinical studies submitted in this NDA in support of the OTC use of 5% Rogaine solution in male androgenetic alopecia are the same studies that were submitted in NDA in support of the Rx use of 5% Rogaine solution in male androgenetic alopecia. The two pivotal studies are summarized as follows.
Does Minoxidil regrow hair?
The FDA says yes. Below are ecerpts from the FDA Medical Offiers report and the results of the actual clinical studies conducted to test the efficacy (Merriam-Webster - the power to produce an effect ) of 5% Minoxidil compared to 2% Minoxidil. These results are the basis for the often quoted "works twice as fast and grows 46% more hair" claims of Pharmacia - Upjohn  which is also included below to complete the story.
Note that these are only the Mens' tests. Also please note that the tests were only conducted on a 1 square centimeter area of the head in the "vertex". A centimeter is approx .4 inches so the hair count data is for less than half a square inch. Herein lies the basis for the hairloss pictures required by the FDA and the "not intended for frontal baldness or a receding hairline" text required on all packaging for Men.
The comments below by Shala Farr of the FDA illustrate one of the interesting minoxidil paradoxes which is that Men are instructed to use it on the top back of the head and Women are instructed to use it on the entire middle section front to back? These clinical trials shed no light on this issue other than to absolutely correlate these clinical trial results with the current FDA required packaging and labeling. If you read the first line of the Label on a Rogaine Extra Strength for Men Box, right after Active Ingredient: minoxidil 5%, it says Use: to regrow hair on the scalp.
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Minoxidil and Rogaine Stop Hair Loss