New heartburn drug works better than the old

In patients with painful inflammation or ulceration of the esophagus due to acid reflux, the investigational drug TAK-390mr achieves better healing rates and controls stomach acid and heartburn for longer than Prevacid (also called lansoprazole).

That’s according to pooled data from two late-stage clinical trials presented by Dr. Prateek Sharma of the University of Virginia in Charlotte at “Digestive Disease Week 2008.”

In an interview with Reuters Health just prior to his presentation, Sharma said TAK-390mr has “a dual-release delivery system.”

“It has two peaks,” he explained. In the first peak, occurring within an hour of taking it and similar to Prevacid, about 25 percent of the drug is delivered. The second peak takes place between 3 and 5 hours later, when the remaining 75 percent is delivered. The effective time is more than doubled (compared with Prevacid), “and therefore it’s better at controlling acid, so that healing can occur.”

The studies involved 4,092 adults with erosive esophagitis, which is associated with acid reflux disease, who were randomized to 60 mg or 90 mg TAK-390mr or Prevacid, 30 mg, daily. TAK390mr is a new formulation of Prevacid.

After 8 weeks, the healing rates in one study were 92.3 percent and 92.2 percent with 60 mg and 90 mg TAK-390mr, respectively, compared with 86.1 percent with Prevacid.

In the second study, the healing rates were 93.1 percent with low-dose and 94.9 percent with high-dose TAK-390mr compared with 91.5 percent with Prevacid. These differences favored TAK-390mr, but did not reach statistical significance.

However, healing rates were “significantly better” with TAK-390mr in patients with more severe erosive esophagitis, Sharma reported, “and the higher dose was superior to the lower dose.”

With TAK-390mr, “patients remained 96 percent to 97 percent heartburn-free”, Sharma said. “When I first saw this data, it knocked my socks off.”

TAP Pharmaceutical Products, Inc., of Lake Forest, Illinois plans to apply for FDA approval of TAK-390mr later this year.

By Martha Kerr
SAN DIEGO, (Reuters Health)