- FDA granted Fidia Pharma premarket approval for its hyaluronic acid injection, called Triluron, designed to treat knee pain due to osteoarthritis, according to documents posted this week.
- The sterile mixture is made up mostly of a highly purified sodium hyaluronate that is derived from rooster comb and administered as an injection into the knee. An indicated treatment course is three injections per week in patients who do not get adequate relief from painkillers or exercise and physical therapy.
- Fidia's study of 373 patients showed comparable pain relief from Triluron injections into the knee joint, compared to patients who received injections of Hyalgan, a Fidia product approved with the same formulation in 1997 but which required five weekly injections as opposed to three.
Osteoarthritis, which cannot be reversed, occurs when the protective cartilage at the ends of the bones wears down over time, most commonly affecting joints in the hands, knees, hips and spine. Hyaluronic acid injections are one treatment option when a patient is no longer able to control pain from osteoarthritis with ibuprofen or other nonsteroidal anti-inflammatory drugs or can't tolerate those drugs.
Hyaluronate is a natural chemical found in the body and is present in high amounts in joint tissues to act as a lubricant. In osteoarthritis, there may not be enough hyaluronate in the joint.
Fidia is one of several companies making hyaluronic acid treatments from rooster combs, according to the Arthritis Foundation. The foundation said some studies of hyaluronic acid have produced disappointing results, but a number of doctors say the weight of scientific evidence and their own clinical experience suggests the shot in the knee can produce significant relief for some patients.
Florham Park, New Jersey-based Fidia Pharma USA, a unit of Italian pharmaceutical manufacturer Fidia Farmaceutici, last month introduced its first orthobiologic, an injectable allograft derived from donated placentas obtained through cesarean delivery. That product, called NuDyn, is intended to complement the company's hyaluronic acid-based products Hyagan and Hymovis to treat osteoarthritis knee pain, Fidia said.