FDA OKs new Nexium formulation
AstraZeneca said Tuesday a new formulation of its blockbuster heartburn treatment Nexium has won FDA approval.
Like its capsule counterpart, the new delayed-release oral suspension version of Nexium is designed to treat gastroesophageal reflux disease and reduce the risk of non-steroidal anti-inflammatory drug associated stomach ulcers, AstraZeneca said.
“Some patients with acid-related diseases have difficulties swallowing their oral medication when it is a solid pill,” said Nexium development leader Doug Levine in a statement. “This new prescription option to swallow an oral suspension of Nexium, or to have it administered via a stomach tube, provides patients with an alternative method of administration.”
Nexium was the third best-selling global prescription drug brand for 2005, with sales of $5.7 billion, according to figures from IMS Health.
Nexium was also third best in the US prescription drug market during 2005, with sales of $4.2 billion.
The new Nexium formulation will be available in the first quarter of 2007, AstraZeneca said.