Duzallo is good for Hyperuricemia in patients with uncontrolled gout – FDA

The FDA has confirmed Duzallo (Ironwood Pharmaceuticals, allopurinol/lesinurad) as a therapy for hyperuricemia linked with gout in patients who are yet to hit the target serum uric acid levels with a healthy dose of allopurinol strictly. However, the once-daily oral therapy is not meant for the alleviation of asymptomatic hyperuricemia.

Duzallo’s efficacy

Duzallo stands out as one of the FDA-approved therapy for hyperuricemia that mixes the immediate standard care for hyperuricemia and the Iesinurad (Zurampic, Ironwood Pharmaceuticals)to provide treatment for hyperuricemia. It offers a dual action in just a tablet that can cure both the under secretion and overproduction of serum uric acid, which are the fundamental causes of hyperuricemia.

Gout is a painful and symptomatic type of inflammatory arthritis which is often caused by hyperuricemia or a high level of serum uric acid in the human blood. This can cause severe pains and other long-term health complications.

FDA approved Duzallo based on the clinical exercise supporting the pharmacokinetic study and lesinrad new drug application (NDA) that analyzed the biological equivalence of the fixed-dose merging of allopurinol and lesinurad as compared to the separate administration of the two drugs. The effectiveness and safety of allopurinol combined with lesinurad were shown in two stage 3 distinct clinical trials.

In the clinical analysis of adults with gout who couldn’t reach the healthy serum uric acid levels when on allopurinol alone, the combined healing power of allopurinol and lesinrad showed a more significant effect on patients, making the reach the target serum uric acid quick.

Adverse effects

The negative effects of the therapy during the clinical tests were influenza, headache, high levels of blood creatinine, as well acid reflux. Duzallo warns about the potential risk of acute renal failure, which is linked with lesinurad, a component of the drug.

The senior vice president of marketing and sales who is also Ironwood’s chief commercial officer, Tom McCourt, said in a press release that the drug would be a significant effort of the firm’s commitment towards curbing gout. And the drug is expected to bring in about $300 million annually just in the U.S. Ironwood hopes the drug will be ready by the fourth quarter of this year.