Co-administration or co-formulation with the BAS Boosters can be used to reduce
the drug dose required to achieve therapeutic efficacy. Prominent drugs
where the boosting principle with CYP 3A inhibitors has been successfully
demonstrated include ketoconazole with the immunosuppressant cyclosporine
in the treatment of transplant patients, and ritonavir with HIV protease
Use of the BAS Booster may result in the elimination or reduction of food effects,
reduction in pill count or reduction in dosing frequency- all factors that
would simplify a therapeutic regimen and enhance patient compliance.
Conversion of parenteral
drugs to oral doses:
Certain drugs exhibiting pronounced degradation by CYP 3A are administered
intravenously (IV) in order to avoid the first pass effect. In some cases re-formulation
with the BAS Booster may be effective in enabling oral dosing. A class of drugs
where conversion has been demonstrated with CYP 3A inhibitors is the taxanes
(i.e., paclitaxel and docetaxel).
Oral dosing will generally be a much more cost effective therapy than IV because
of the elimination of hospital and ancillary costs. It is a method of treatment
normally preferred by the patient.
Resurrection of failed
There are no reliable methods for predicting the oral bioavailability of drugs
in development. A major reason for candidate drugs failing to reach market
is because of bioavailability issues encountered during development programs.
Candidates degraded by CYP 3A may have their efficacy enhanced sufficiently
by the use of the BAS Booster to make the difference in progressing to market.
Rescuing drug candidates in this manner could recapture considerable sunk investment
by pharmaceutical companies.
Extending patent life:
Re-formulation with the BAS Booster could be an effective strategy for extending
the patent life of established drugs and for generating improvements
in therapy attractive to physicians and patients that can be leveraged
to compete with generic products.