New Approvals

FDA Approves New Drug For Gout

Fda approval

Gout is a disease of joints that occurs due to high serum uric acid and  usually occurs in older people and more commonly in males (90%). In females it often occurs during the postmenopausal periods. The Commonest joint involved is the metatarsophalangeal joint of the big toe, ankle, knee and other joints can also be involved.

  • The FDA has approved a new fixed-dose combo (i.e Duzallo :A combination of lesinurad and allopurinol) for the treatment of  hyperuricemia in patients with uncontrolled gout.
  • Duzallo, manufactured by Ironwood Pharmaceuticals,designed to achieve target serum uric acid  levels in patients who cannot do so with allopurinol alone.
  • Duzallo is the first FDA-approved fixed-dose combo that addresses both underlying causes of hyperuricemia in gout, over-production and under-excretion of serum Uric Acid, in a single oral tablet.
  • Duzallo contains lesinurad 200 mg plus allopurinol 300 mg. It is also available in a lesinurad 200 mg plus allopurinol 200 mg dosage. It should be taken in the morning with food and water, and patients should be advised to stay well hydrated when taking the medication.
  • According to the company’s press release, Duzallo is expected to be available in the market in 8th or 9 th month of 2017.
  • The FDA’s approval is based on a clinical studies supporting the new drug application for lesinurad (Zurampic), as well as on the results of a pharmacokinetic study that evaluated the bioequivalence of the fixed-dose combination of lesinurad and allopurinol compared with co-administration of separate tablets.
  • In phase 3 clinical trials of adult patients with gout who failed to achieve target serum Uric Acid levels on allopurinol alone, Duzallo nearly doubled the number of patients who achieved sUA target after 6 months.

Adverse Effects of New Drug For Gout

The most common ADRs included

  • influenza,
  • Higher levels of blood creatinine,
  • headache and
  • heartburn.
  • Additionally,Duzallo has FDA warning regarding the risk of acute renal failure.
  • Also It is not recommended for the treatment of asymptomatic hyperuricemia.

Source: Ironwood Pharmaceuticals Press

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