Apricus Biosciences, Inc. announced that its wholly owned subsidiary, NexMed USA, has received clearance from the US Food and Drug Administration (FDA) to market its second, over-the-counter (OTC) anti-itch drug, Hydrocortisone-D, containing the company's NexACT technology.
“This is the second clearance by the FDA of a drug containing Apricus Bio's NexACT drug delivery technology, and as such, enhances our strategy of building out our OTC products division and creating a new revenue-generating portfolio for the Company,” explained Dr Bassam Damaj, chairman, president and chief executive officer of Apricus Bio.”
The active ingredient in the cleared OTC drug, hydrocortisone, is an already approved anti-itch agent, which can be sold as a cream. It is currently used to treat itching associated with minor skin irritations, inflammation and rashes due to eczema, insect bites, poison ivy, poison oak, and psoriasis (among others). It is sold under several third party brand names, most notably Cortizone (Chattem/Sanofi Aventis) and Cortaid (Johnson & Johnson).
Apricus Bio's new Hydrocortisone-D product combines hydrocortisone with DDAIP, the main ingredient in NexACT, the company's proprietary drug delivery technology. NexACT temporarily loosens the tight junctions between skin cells to allow more permeation.
“Since January we have been working on building out our OTC portfolio. With Tolnaftate-D having been cleared last week and Hydrocortisone-D coming in this week, we are creating a new division that can contribute to both near-term revenues and long-term growth,” stated Dr Damaj.
According to the FDA, OTC products can be marketed under the authority of an approved product-specific New Drug Application (NDA) or an Abbreviated NDA (ANDA), or under an OTC drug monograph. Unlike NDAs, which are based on drug products, monographs specify the active ingredients that can be contained in OTC drug products. In addition to specifying the active ingredients, the OTC monographs contain information regarding the permitted concentrations of active ingredients, dosage limits, indications, and other requirements for legal marketing under monograph status.
Apricus Bio, a revenue-generating, biopharmaceutical company, has leveraged the flexibility of its clinically-validated NexACT drug delivery technology to enable multi-route administration of new and improved compounds across numerous therapeutic classes.