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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.