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MDF topical from Samson Therapeutics (Topicals)

posted by RonLev, 25.05.2008, 15:40

» » » Even worse, the studies with topical flutamide
» » » in animals have shown very serious problems with
» » » systemic absorption of the drug.
» »
» » It is well known that flutamide has a relatively high rate of
» percutaneous
» » absorption (16% in the study you are undoubtedly referring to, Katchen,
» » 1976), but those studies were using the dosage level for oncologic
» » indications (pro-rated in animal models from a base of 750 mg in
» humans).
» » In subsequent years, investigators have titrated the dose downward to
» » determine its safe level for nononcologic use. These series of studies
» » were conducted by Muderris in 1999 and 2000, who found that using
» levels
» » <250 mg were entirely safe (we use the very lowest dose Muderris found
» that
» » was still effective at 62.5 mg and created the topical equivalent,
» which
» » results in a systemic absorption of only 10.3 mg--far below the level
» that
» » produces any systemic effect).
»
» I'm pleased to know that the ABSOLUTE quantity of absorbed flutamide from
» a typical application/dose of your product is probably low enough not to
» present any obvious toxic symptoms, but nevertheless I was mainly
» referring in my post above to the animal studies(1,2) showing that
» topically-applied flutamide works entirely by SYSTEMIC absorption. In
» other words, I'm not aware of any scientific studies showing a "local"
» effect of topical flutamide except for that one Sintov study, and I don't
» consider that one to be entirely persuasive. Do you and your company
» realize that what you're doing is putting out a VERY expensive product
» which uses a potentially VERY toxic drug which is based on exactly ONE
» rather questionable animal experiment claiming a certain degree of "local"
» efficacy?
»
» 1) "Local and systemic reduction by topical finasteride or flutamide of
» hamster flank organ size and enzyme activity." J Invest Dermatol 1995
» Nov;105(5):678-82.
»
» 2) "The effects of a nonsteroid antiandrogen, flutamide, on sebaceous
» gland activity". J Invest Dermatol 64:412-417, 1975.
Bryan,

I appreciate your "dedication" to questioning us on a holiday! Let me answer your assertions directly,

1. “VERY EXPENSIVE”. As I noted earlier, we are providing 3 potent agents at a per-day price of $1.61, a cost that is well within the normal market range of such products. I should mention that the raw-materials cost of most drugs constitute a very small portion of their cost to the patient. For big pharma, much of the cost is invested in marketing. The bulk of our cost is sunk into the vehicle development, our ongoing quality controls and the cost of custom compounding each Rx individually by a skilled pharmacy technician. That is why the price of the 1-month size of MDF is not much lower than the price of the 3-month size—most of the cost is fixed, there is little variable cost by volume in our operation.

2. You seem to have contradictory views about effectiveness. You (correctly) state that flutamide has shown a systemic effect, but then you assert that no local effect can be assumed without clinical studies. However, normal pharmacokinetic partitioning requires a drug to traverse the dermis (where the hair follicles reside) and cumulate a significant concentration there before it can pass into the systemic circulation. Therefore, a drug that demonstrates a systemic effect MUST have a local effect, if there are susceptible receptors there. As I mentioned earlier, pharma companies are not interested in pursuing topical studies, so dermatologists have traditionally adapted many products for topical use on the basis of the oral and systemic pharmacology that is available.

3. “VERY TOXIC” (?) As a result of titration studies throughout the past 9 years, the safety of flutamide has been well established, and doses up to 250 mg qd have been used ORALLY (where the systemic absorption is nearly 100%) in women with hair growth disorders by dermatologists with no ill effects. By contrast, we are using 62.5 mg topically in men (where the systemic absorption is 16%) yielding a systemic exposure of only 10.3 mg.

RonLev

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