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"New drug marks COX-2 comeback"

Source: Medical Post

Published: 21 Nov 2021

Category: Pharmaceutical

Rating: (3 stars)

what they said (Hover the mouse cursor over underlined words for more info)

Lumiracoxib launch expands options for osteoarthritis Rx; post-marketing study a condition of approval

TORONTO | With the approval earlier this month of lumiracoxib (Prexige), Canadian physicians have a new COX-2-selective inhibitor at their disposal for the first time since safety concerns led to the withdrawal of two previous medications in this class.
Lumiracoxib will be available in pharmacies across the country by the end of November, according to manufacturer Novartis, and will be indicated for acute and chronic treatment of osteoarthritis (OA) of the knee in adults, in a once-daily 100 mg tablet....

The original article can found in the Media Doctor archives.

how did it rate? (more information)

Criteria	Rating
Total Score	6 of 10
Availability of Treatment	Satisfactory (?)
Novelty of Treatment	Satisfactory (?)
Disease Mongering	Satisfactory (?)
Treatment Options	Not Satisfactory (?)
Costs of Treatment	Not Satisfactory (?)
Evidence	Satisfactory (?)
Quantification of Benefits of Treatment	Satisfactory (?)
Harms of Treatment	Satisfactory (?)
Sources of Information	Not Satisfactory (?)
Relies on Press Release	Not Applicable
Quantification of Harms of Treatment	Not Satisfactory (?)

what we said (Hover the mouse cursor over underlined words for more info)

Since it was written for a physician audience, it has a somewhat more sophisticated approach than articles written for the general public, and side effects are well documented. However, I am surprised that there is no mention of effectiveness of the new drug relative to presently available agents.

While the article describes the difference between the drug and its comparator using relative numbers, it uses absolute numbers to describe the benefit for each cohort "Among patients not taking ASA, the cumulative one-year incidence of ulcer complications was 1.09% in the traditional NSAID group and 0.25% in patients on lumiracoxib-a 79% reduction."

One might say that the data derived from this study is really of limited use. Despite being described as the "largest trial in history to evaluate the safety of an anti-inflammatory drug before it was launched," we learn that the study excluded most people with any form of cardiovascular conditions, such as a history of myocardial infarction, stroke, bypass surgery or angioplasty. This would surely limit the generalizability of the findings.

The most serious failing in this study is not getting any critical comment from anyone not involved in the study or from anyone who is not enthusiastic about a new coxib.

public forum

(23 Jan 2022) Novartis insider - used to be writes,

"Here is another interesting or even funny fact about the introduction of this new drug by Novartis.
As we speak,they have their PREXIGE launch national meeting in, get this LAS VEGAS the gambling paradise. Is there a message there for us or just coincidence? Yes any introduction of new product even drug is risky, but maybe a gamble?
As suggested above, lets watch what happens while those who always must have the newest and latest take it for their pain. We hope they are not GAMBLING, again."
(this comment has been moderated)

Media Doctor response,

"We will continue to monitor this and other Cox-2 drugs as they appear in the media."

(21 Jan 2022) Peter from Private indiv. writes,

"Hopefully this so called comeback will not be short lived. Many pople need a better drug for their conditions and we all hoped that Vioxx and its sisters or brothers would have done a job that their relentless promotion and hype promised.
The short comment above already points out the problems with this longest and largest study which might have been "cusom" made for Novartis so to look really good. Personally I will wait just as in the case of brand new car put out on the market. It may turn out that this "new car" is based on PINTO (read Vioxx) and may give you all the problems as the original.
The Canadian regulatory authorities must watch their promotion to make sure it sticks with the approved indication. This as most our big pharma companies tend to "expand" their indications beyond the approved by clever manipulation of their promotional efforts and physicians at large. For this they also as usually have full support of "their" specialists especially ones that participated in trials.
The fact that none of these made any comments indicates they are pretty well sticking to the script given to them by their "frinds" at Novartis.
This one will be interesting to watch. One thing we have to admitt , Novartis does have nerv and big b..s. along with unlimitted financial resources."

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