New drugs not yet available

Lorcaserin

Lorcaserin/BelviQ

In June 2012, the US Food and Drug Administration approved our internally discovered and developed drug, BELVIQ® (lorcaserin HCI).
We are also seeking regulatory approval for lorcaserin in the European Union, and intend to seek regulatory approval for lorcaserin in additional territories. Regulatory agencies outside the US will independently review lorcaserin.
Our wholly owned subsidiary, Arena Pharmaceuticals GmbH has granted Eisai Inc. exclusive rights to commercialize lorcaserin in most of North and South America, including the United States, Canada, Mexico and Brazil, subject to applicable regulatory approval.
We have patents or patent applications that cover lorcaserin in the United States, Europe, Canada, Mexico, Brazil and many other jurisdictions that, if issued, in most cases would be capable of continuing into 2023 without taking into account any patent term extensions or other exclusivity we might obtain.

BELVIQ will not be available for sale in the United States until after the Drug Enforcement Administration of the US Department of Justice determines BELVIQ’s final scheduling designation.

Qnexa/Qsymia

FDA Approves Qnexa

July 18th, 2012 by MorganDowney Leave a reply »

Vivus Inc. announced today that the Food and Drug Administration (FDA) has approved its anti-obesity drug, Qnexa^, which has been renamed Qsymia^tm .  Qsymia^tm is a combination drug, composed of phentermine and topiramate, both of which have been approved by the FDA for years. As we have previously reported, Osymia^tm has the most impressive weight loss of any obesity drug. The FDA has recommended patients discontinue the drug if they lose less than 3% of body weight on the mid-dose formulation or less than 5% on the high dose after 12 weeks. They also recommended monitoring of heart rate for people on the drug and that women of child-bearing age have a negative pregnancy test every month while using the drug. A Risk Evaluation and Mitigation System (REMS) plan includes distribution through certified pharmacies, a medication guide and a timetable for assessments.

The Risk Evaluation and Management Strategy information, Medication Guide, Safety Information and Health Provider Training Program can be accessed at: http://www.qsymiarems.com/

New drugs for obesity treatment

Finally, after rejecting many times new options to treat obesity from the pharmaceutical industry, the FDA has given its blessing to two new drugs, Lorcaserin and Qnexa. Both drugs aide in appetite control. They both have been able to produce at least a loss of 5% of total weight compared to placebo and no more than that.  So, the message to patients is still the same. No matter how many drugs we can use, if you can not control the calories, there will be no miracle. these drugs as the ones currently in use will not operate the change, you will. But still it is a great thing to be able to count on more options to help you with the process. Lorcaserin is a new drug, Qnexa is a combination of two drugs, Topiramate and Phentermine, that we already use of label, is just that now we have the blessing of the FDA and hopefully your insurance will cover it if indicated.
Please read below the information on Lorcaserine, I will also add something on Qnexa.

FDA Approves Lorcaserin

June 27th, 2012 by MorganDowney Leave a reply »

The Food and Drug Administration announced today that it has approvedlorcaserin (to be marketed as Belviq)for the treatment of adult obesity. The drug was developed by Arena Parmaceuticals and went through two advisory committee panels. The final panel voted to recommend approval by a vote of 18-4. This is the first drug for treating obesity approved by obesity since sibutramine was approved in 1997.

Lorcaserin is a novel drug that targets a specific serotonin receptor. It was a different serotonin receptor which was implicated in heart valve problems associated with use of the dexfenfluramine component of Fen-Phen. The FDA briefing document for the Advisory Committee meeting on May 10, 2012 states  that it “is unlikely at the proposed clinical dose” will activate the receptor implicated in the heart valve problem.

The receptor lorcaserin does impact is concentrated in the central nervous system (CNS) and regulates feeding behavior.

In the latest published study of the drug, the BLOOM-DM study led by Patrick O’Neil, 604 patients who were obese or overweight with type 2 diabetes were randomized into a treatment group and a placebo group. Both groups received lifestyle counseling. The group on drug lost 4.5-5% of their initial body weight while the placebo group lost 1.5%. PubMed: Clinical Trial of Lorcaserin in Type 2 diabetes Weight loss in patients with type 2 diabetes is notoriously difficult to achieve.  A 5% weight loss is considered to provide clinically meaningful changes. Weight reduction was evident at 2 weeks which means that patients who don’t see weight loss are likely to discontinue use early on in treatment. Glycemic control improved more in the lorcaserin group. There were not significant changes between the group on drug and on placebo in regard to cholesterol, triglycerides and blood pressure. The lack of statistical significance may be due to the use by a majority of patients being on blood pressure or lipid medications at the start of the trial.

Arena Pharmaceuticals, developer of lorcaserin, has agreed to conduct a number of post-approval trials, including one to assess cardiovascular effects.