Medexus Pharmaceuticals (MDP.V) announced that they’re making their Triamcinolone Hexacetonide (TH) Injectable Suspension, USP (20 mg/ml) available in the United States through the FDA’s CDER Drug Shortage program in response to a shortage of the drug, according to a press release.
There’s a lot of moving parts to this one, so settle in and I’ll try to make it as painless as possible.
Before we get into it, though, Medexus is a North American pharmaceutical company involved in finding treatments for rare diseases. They come with a foundation of proven best in class products and are presently developing their portfolio to include high value orphan and rare disease products that they’re banking on being the linchpin for growth over the next ten years.
Their core products are Rasuvo™ and Metoject®, IXINITY® and Rupall®.
The first two are treatments for rheumatoid arthritis and other autoimmune diseases, while IXINITY works on Hemophilia B to control bleeding characterized by a deficiency of a clotting agent in the blood, and lastly, Rupall handles allergies.
What does TH do?
Now that we’re up to speed on who we’re talking about, let’s get to the moving parts.
First, TH is commonly used in a wide variety of conditions, including allergic disorders, arthritis, gout, blood diseases, breathing problems, certain cancers, eye diseases, intestinal disorders, collagen and skin diseases.
It’s indicated for intra-articular (injected into a joint), intrasynovial (or into a small fluid-filled sac found at certain joints) or peri-articular (injected around a joint) use in adults or teens with certain types of joint diseases, including rheumatoid arthritis, juvenile idiopathic arthritis, osteoarthritis, and post-traumatic arthritis, as well as synovitis, tendinitis, bursitis and epicondylitis.
Medexus is also coordinating with its licensing partner, Ethypharm, to tackle the ongoing TH shortage in the United States. They’re generating the data required in support of seeking out an expedited Abbreviated New Drug Application (ANDA) file.
An ANDA includes data submitted to the FDA for review and potential approval of a generic drug. Upon approval, the company can manufacture and market the generic drug to provide a safe, effective, and most importantly, low-cost alternative to the brand name drug it’s copying. The product is comparable to an original drug (say—generic fluoxetine is to brand name Prozac) in every way—dosage form, strength, administration route, quality and performance, and intended use.