There exists a perception by many people who have clinical experience in the area of psychoactive substances that the pharmaceutical development of such a product would be fraught with problems. This has not been NDA International, Inc.'s experience. We are, however, at an early stage in our work.
It had been demonstrated that the FDA would not allow the marketing of any product on broad-based claims of psychotherapeutic efficacy. While our original interest in Ibogaine was as an adjunct to psychoanalytical and psychotherapeutic treatment, our reason to proceed with the development of Ibogaine was its unique ability to interrupt chemical dependency disorders. This allowed for a very specific application to a long term public health problem which heretofore had been provided with no successful means of medical interruption.
The keys to marketing any pharmaceutical product are patent protection, proper financing and a clear understanding of the regulatory requirements which must be met. The ENDABUSE PROCEDURE - in which Ibogaine may be used to interrupt heroin, cocaine, alcohol or nicotine addiction are the only research areas for which NDA International will supply Ibogaine for human treatment. That Ibogaine is a schedule 1 substance was a circumstance we viewed as positive in that only responsible researchers would have access to the material.
One of the reasons I believe that we have not run into any significant problems is that we are following normal guidelines for pharmaceutical development and not seeking special accommodations from regulatory agencies. Furthermore, NDA International is well represented by legal specialists in the regulatory and patent areas.
A second reason I believe research is proceeding without problem is that NDA International has a clear understanding of who our medication is intended for: Addicts. Our corporation has a policy of not providing Ibogaine to satisfy the professional curiosity of psychiatrists and psychologists as to its effects. It is no more necessary for a medical specialist to take Ibogaine to treat addictive disorders than it would be for an oncologist to take anti-cancer drugs in order to treat patients suffering from cancer. Thus, a clear distinction exists between satisfying physician curiosity and treating addicted patients.
There are inherent advantages to Ibogaine which lend themselves to allow the development of this product:
In order to place Ibogaine in correct perspective, it must be remembered that many psychoactive substances are already available for medical use. The belladona alkaloids (cold preparations), dextromethorphan (cough medications), vincaleukoblastine (anti-cancer drugs) and valium (anti-anxiety agents) are all capable of causing hallucinatory reactions. In the case of Ibogaine, an anti-mnemonic repression agent, all visualization appears to cease after three or four treatments. While our conclusions are highly speculative, it may be that once repressed memories are released during the ENDABUSE PROCEDURE (tm), visualization ceases. Thus, Ibogaine is not an hallucinogen.
I hope that in this brief review, the reader will have been provided with a general understanding which may lead to the further development of valuable medical products.
For more information about Ibogaine, contact:
46 Oxford Place
Staten Island, NY 10301