The makers of the proposed weight-loss drug Contrave said this week they have taken a key first step in showing that the medication does not boost the heart and stroke risks of those taking it, and they announced plans to return to the Food and Drug Administration to seek its approval in the coming weeks.

Contrave, an investigational drug that pairs the antidepressant and antismoking drug bupropion with the anti-addiction medication naltrexone, could be approved by the drug agency for the U.S. market as early as June.

In June and July of 2012, the FDA approved the marketing of Belviq and Qsymia. But Contrave, the first of the three to come before the agency for approval, was rebuffed by the FDA in February 2011. Its sponsor, La Jolla, Calif.-based biotech company Orexigen Therapeutics Inc., was told its application would be reconsidered if it sponsored a clinical trial that demonstrated that obese patients taking the drug did not have a significantly higher risk of suffering heart attack, stroke or cardiovascular death than those who did not take the drug.

This week, Orexigen announced it had reached the interim target laid out by the FDA. At 300 centers across the United States, it enrolled 9,000 obese patients at higher-than-usual risk of cardiovascular disease into the “Light study” and assigned them randomly into a group that took the medication and a comparison group that got a placebo pill. Four in 10 of those participants had Type-2 diabetes, and virtually all were taking medication for hypertension, high cholesterol or both.

After 87 cardiovascular “events” had taken place among subjects enrolled in the trial, the investigators set out to explore whether strokes, heart attacks or cardiovascular death among those taking Contrave were within the bounds laid out by the FDA as a preliminary target. They were, clearing the way for a resubmission as early as December and an FDA decision in June.

“It’s a big milestone for us,” said Orexigen President and CEO Mike Narachi in an interview Wednesday. Narachi added that Contrave is also under consideration by the European Drug Agency, and predicted the interim findings would bolster that application as well. He said that if the drug were approved, Orexigen and its partner, Takeda Pharmaceuticals, would launch a large and well-funded campaign to market the medication to physicians and patients.