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Lorcaserin or Lorqess: Analysis of FDA Panel

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This is an analysis of Lorcaserin or Lorqess and the upcoming FDA advisory panel.  If curious or have any questions or want more such analysis, please email dg_writing@hotmail.com – thanks!

Lorcaserin or Lorqess is going up for an FDA advisory panel on September 16, 2010.  It is an obesity drug that has generated a lot of excitement.  Advisory panels consist of experts who meet to discuss whether a drug should or should not be approved.

They are not binding.  The FDA can listen or ignore their advice.

This panel comes after two unfortunate events.  First, the negative reception of another obesity drug, Qnexa, a few months back, where a panel voted against its approval.

Second, it is taking place the day after a discussion on the obesity drug Meridia which has been linked to serious safety concerns.

The panel will look at two key things: Efficacy, and safety

Is Lorqess effective?

Is Lorqess safe?

With all medications, it is a balancing act.  A drug that doesn’t work so well but has perfect safety is a lot different from a drug that works great but has significant safety concerns.

With Qnexa, there was a lot of efficacy, and some significant concern about safety.

With Lorqess, it is the opposite: limited efficacy, and limited safety concerns.

Here are the main concerns with Lorqess:

1) It barely works.  There are two main ways to measure efficacy of an obesity drug.  Lorqess only barely meets one of the criteria, which is enough – but it is the less preferred criteria.

As is, Lorqess seems to meet the standard for approval of an obesity drug, but just barely.

2) It has to be taken for life

Not many people have noticed this nasty twist, but it is something that will weigh on panelists minds.  I looked at a graph of weight after one year on Lorqess and then a year off.

All the lost weight was regained in that graph.  It actually ended a little higher than those on placebo for two years.

Stopping Lorqess seems to mean you regain the weight.

This was one graph from one study, however.

3) It is similar in chemical action to another weight-loss drug that was linked to a massive health failure

Lorqess has almost identical chemical action to the infamous fenfluramine from the phen-fen combo.

4) It is likely to be used in combination with other drugs

Because of its limited efficacy, panelists are likely to wonder: What will happen if Lorqess is taken with other drugs, hoping to increase the weight loss?

In favor of Lorqess:

1) Obesity is widely viewed as a public health epidemic

2) It has two years of safety data and the safety data so far has been very good with limited problems

3) It does meet the criteria for approval for an obesity drug

Conclusion:

Advisory panels are strange and unpredictable.  Lorcaserin or Lorqess seems to meet the standard for approval as is.  That said, advisory panels are very political and may have a different perspective than the FDA.

Due to the potential for a variety of issues to be raised that could cause significant hesitancy combined with the poor timing, I would estimate: 60% chance of  negative vote, 40% positive.



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This post was written by on Monday, September 6, 2010. This author has written 223 posts on this blog and has 4978187 total posts views.


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4 comments

  1. The “If you stop taking it” senario is true for every diet pill (the ugly truth), not just Lorqess/Lorcaserin. If Lorcaserin is approved, medically speaking it could be combined with Phentermine. I think the safety issue is ok, but I agree with it barely working and that is what the advisory committee will be hung up on.

  2. The flaw in the FDA logic centers around the “return of weight” argument which in an unfair measuring stick that not all drugs must adhere to. For example, if you stop taking your cholesterol medication and you don’t change your diet, your cholesterol will return to pre-drug levels. The same is true with diabetes medications. Safety must surely be closely examined, but there should also be consideration for the epidemic of weight gain and obesity in this country which has been proven to cause a whole host of other health related issues (heart disease, diabetes, etc.). There needs to be a balance.

  3. Unfortunately health (therefore long-term weight loss) does not come in a pill. Making small healthy lifestyle changes will lead to weight loss if you have weight to lose. Losing excess weight takes time and effort but it is worth it. Check out this amazing blog to make simple health changes that are easily applied to our busy lifestyles.

    http://blog.mydiscoverhealth.com/

  4. I was in the study for Lorqess lorcaserin and it worked.  I lost 62lbs. and have never been able to lose it before.  I need someone to contact me about this medication as I have gained some of the weight back and don’t mind taking it again.  It made me feel so much better.  

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