This article updates an earlier review (1) on this subject to include developments from the years 2007-2014, in particular, new drug formulation approvals and changes in the regulatory affairs associated with the use of Dimethyl Sulfoxide Topicals.
The November 2009 launch of Pennsaid (diclofenac sodium topical 1.5%) was notable in that it was the first DMSO-containing topical formulation to obtain FDA marketing approval.
These products have been marketed in Europe and the former Central and Eastern European (CEE) and the Commonwealth of Independent States (CIS) countries for many years.
The Pharmacircle database (6) discloses the use of DMSO in Actikerall and Verrucare, for the treatment of actinic keratosis (grade I/II) in adult patients.
It lists capsaicin, methyl salicylate, and menthol USP as active ingredients.
Pennsaid 2% is also composed of 45.5% w/v Dimethyl Sulfoxide USP.Some roles for DMSO in injectable products include as a vehicle for the delivery of medical polymers--viz.poly(lactic-co-glycolic acid) (PLGA) and polylactic acid (PLA)--and as a preservation media in stem-cell therapeutics.An ophthalmic idoxuridine product (Antizona) was sold by Sanofi-Aventis.There are other topicals, which include DMSO as an excipient, that have been approved outside of the US.