A Year After FDA Approval, Belviq is Available to U.S. Patients

According to the latest release from Arena Pharmaceuticals, its prescription weight loss drug, Belviq, has been released this week. This has brought the launch to almost a year after the medication received its official approval from the FDA.

In June 2012, the Food and Drug Administration gave the nod to Belviq (which has the generic name of lorcaserin) for use by adults who are either obese or who are overweight and have at least one serious medical condition associated with the excess pounds, such as high cholesterol or diabetes. This made the drug the first one meant for weight loss that had received FDA approval in about thirteen years.

Even though the participants in the clinical studies for Belviq showed only moderate weight loss results, the drug was deemed safe enough for use by the FDA in order to receive its approval. This decision was likely encouraged by the calls being made from doctors for new treatments to help to overcome obesity.

Despite the FDA approval, the drug experienced months of delays due to a number of different logistical struggles, including Drug Enforcement Administration classification. The Belviq label will now call these pills a Schedule IV controlled substance. This indicates that there is a low risk of possible abuse. Among the participants in the clinical studies, a small number reported experiencing hallucinations and euphoria.

According to the release from Arena Pharmaceuticals, along with Eisai Co., its partner, the drug became available on Tuesday (June 11, 2013). The agreement that was established between these two companies allows Arena to be the Belviq supplier and manufacturer through its Switzerland facility, while Eisai will be responsible for marketing these pills in the United States.

Due to the weight loss drug’s launch delays, it is actually becoming available to American consumers a full 10 months after the drug called Qsymia from competitor Vivus. That weight loss drug was launched in September 2012, despite the fact that its FDA approval was received after that of Belviq. The clinical studies involving Qsymia indicated that it generates a larger amount of weight loss than the use of Belviq.

In the clinical research, patients who were taking Qsymia over a period of a year in one study were able to lose 6.7 percent of their body weight, while another study showed that they lost 8.9 percent in the same period of time.

Comparatively, Belviq weight loss results were about half as beneficial as those from Qsymia, at between 3 and 3.7 percent body weight loss over a period of one year.

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