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Lesinurad/allopurinol fixed-dose combination can be used to address the underlying causes of hyperuricemia i.e.
overproduction and underexcretion of serum uric acid in gout patients.
Excess
of uric acid crystals in a joint causes gout. It is a form of arthritis that
causes burning pain, stiffness, and swelling in a joint, usually a big
toe.
The
new drug application (NDA) for lesinurad/allopurinol fixed-dose combination for
the treatment of hyperuricemia in patients with uncontrolled gout has been
accepted for review by the Food and Drug Administration (FDA).
The
data from the lesinurad clinical trial program and a pharmacokinetic study
gave way to the NDA submission for this drug inspecting the bioequivalence of
the fixed-dose combination compared to lesinurad and allopurinol
co-administered separately.
The
results of this study revealed that the addition of lesinurad to a
xanthine oxidase inhibitor (XOI) almost doubled the number of patients who
accomplished target serum uric acid (sUA) levels of <6mg/dL at month 6.
Also, the fixed-dose combination reduced the mean sUA to <6mg/dL by month 1
and sustained that level through month 12.
Recently,
Lesinurad- a URAT1 inhibitor, was approved in combination with a XOI for
the treatment of hyperuricemia associated with gout in patients. These did not
achieve target serum uric acid levels with a XOI alone. It's increases the
renal excretion of uric acid through the selective inhibition of URAT1-
the transporter responsible for the majority of renal uric acid
reabsorption. Allopurinol is a XOI which decreases the production of uric acid.
As a combination product, it will excercise dual-mechanism which can address the
issues of uric acid.
The
FDA is anticipating the Prescription Drug User Fee Act (PDUFA) target action
date to occur in the second half of
2017. This drug would become the first gout treatment in a daily fixed-dose
combination possessing dual mechanism of action, if approved.
FDA
Ironwood Pharmaceuticals Announces FDA Approval of DUZALLO® (lesinurad and allopurinol) for the Treatment of Hyperuricemia in Patients with Uncontrolled Gout
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