What’s in a brand name, when household income has been squeezed to its very last drop? Rising costs have compelled people to opt for generic meds instead of branded ones to save a few bucks wherever possible. And now, meds for chronic anal fissure pain are set to get a generic version, thanks to pharma company Acrux (ASX: ACR), which specialises in topically-applied pharmaceutical products.

The United States Food and Drug Administration (FDA) has accepted the Company’s application for a generic version (Abbreviated New Drug Application or ‘ANDA’) of Nitroglycerin Ointment, 0.4% for review. Nitroglycerin Ointment, 0.4% is used to treat moderate to severe pain associated with chronic anal fissure (a tear in the anus lining).

Acrux CEO and Managing Director, Michael Kotsanis, said, “We are extremely pleased to advance another product from our pipeline to FDA regulatory review. Our key focus is on the continuing evolution of Acrux into a company with a diversified on-market portfolio and a well-planned pipeline of commercially valued products. Today’s advancement of Nitroglycerin Ointment, 0.4% through to the regulatory submission stage is a great example of our strategy in action.”

The ointment has a total addressable market of approximately $29.8 million. Currently, there are no approved or available ANDA products. However, a commercial partner has been secured and is ready to launch the product as soon as FDA approval is obtained.

FDA has told Acrux that its application has met the necessary requirements and is eligible for review. The reference drug being considered is Rectiv Ointment, 0.4%, which is currently sold in the United States by AbbVie Inc. While the FDA is overseeing the review process, the time it takes to receive final approval depends on the type and number of inquiries that may arise during the FDA’s assessment.

Once the FDA approval is granted, Acrux can proceed with final preparations alongside its existing commercial partner to initiate the marketing and sales of the product in the United States.

The Company aims to bring a range of pharmaceutical products to the market, focusing on topical applications. Several products have already received FDA approval in the United States, including Lidocaine, 2.5% and Prilocaine, 2.5% Cream, which is a topical anaesthetic marketed by Padagis. In addition, Dapsone Gel, 5%, a treatment for acne, was approved in June 2023, and plans for its launch are progressing with the support of our commercial partner and manufacturer.

Another approved product is Estradiol Spray, used to alleviate symptoms associated with menopause, and it is marketed under the brand name Evamist by Padagis. Furthermore, Testosterone Topical Solution, designed to address male conditions caused by testosterone deficiency, is marketed by Dash Pharmaceuticals.

Apart from the approved products, the FDA has accepted and is currently reviewing the following items: Nitroglycerin Ointment 0.4%, which is intended to treat moderate to severe pain resulting from chronic anal fissure; Acyclovir Cream, 5%, a treatment for cold sores; and Dapsone Gel, 7.5%, a stronger acne remedy.

The Company’s primary focus is on advancing later stage projects that are set for commercialisation in the near future. At the same time, it is also making progress in developing earlier-stage products to ensure a diverse product pipeline.

Currently, Acrux has a portfolio of 16 products that stand at different stages of development and commercialisation.