Botulinum Toxin Products

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Latest Botulinum Toxin Products

The latest botulinum toxin products that are expected to hit the market in the nearest future are Jeuveau (Prabotulinum toxin A) and RT002 (daxibotulinumtoxin A). Jeuveau was approved in February 2019 and is expected to be introduced into the market in the spring of 2019. RT002 is projected to be launched in 2020 but is yet to be approved.

Methodology

To find the benefits and drawbacks of RT002, we started our search by exploring the website of Revance, the manufacturer. We found information on the clinical trials of RT002, but we didn’t find information on its benefits and drawbacks.
We then proceeded to search the website of FDA and ClinicalTrials.gov for the results of the clinical trials of RT002 which would likely include its benefits and drawbacks. We found that the trials are expected to be concluded in February 2020 and no result has been posted.
We expanded our search to news media sites like Business Wire and PR Newswire, as well as industry news sites such as BioSpace, Pharmaceutical Technology, and Prime Journal. We only found information on the potential advantage of providing six-month treatment duration compared to the three-month treatment duration of current products. The unavailability of published benefits and drawbacks is expected since the product is yet to be approved. The FDA publishes the benefits and drawbacks of approved products as is the case with Jeuveau.

Jeuveau (Prabotulinum toxin A)

Jeuveau was approved by the FDA on February 1, 2019, and is expected to be launched into the market in the spring of 2019. It is manufactured by Evolus.

BENEFITS

According to results from two product trials, patients who have wrinkles between their eyebrows experienced an improvement in their frown lines after thirty days of treatment with Jeuveau. In the first trial, 67% of patients experienced temporary enhancement in the wrinkles between their eyebrows compared to only 1% of patients who received placebo. In the second trial, 71% of patients experienced temporary enhancement in the wrinkles between their eyebrows compared to only 1% of patients who received placebo.

DRAWBACKS

The most frequent side effects of Juveau include “headache, upper respiratory tract infection, and drooping of eyelid”. Generally, botulinum toxin products could spread from the injected area to other parts of the body which can lead to serious life-threatening consequences like difficulty in breathing and swallowing that could result in death. Other side effects include “loss of strength and muscle weakness, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice, trouble saying words clearly, loss of bladder control, severe allergic reactions, and heart attack”.

PROJECTED MARKET IMPACT

Currently, there are only three botulinum toxin products in the market: Botox, Dysport, and Xeomin. Botox was approved in 1991, Dysport got approval in 2009, and Xeomin received approval in 2010. Industry experts predicted that Jeuveau will likely be a strong competitor to Botox with a projected price reduction of 20%–30%. However, there is uncertainty regarding the expected market performance of Jeuveau compared to Dysport and Xeomin. All the products contain the same toxin.

Jeuveau and Botox can be used interchangeably because their efficacy and safety profiles are alike. The peak sales for Jeuveau in the US in 2022 is projected to be $300 million. A vial of Botox costs around $500, hence a 20%–30% price cut for Jeuveau would give about $350–$400 and this would place Jeuveau on a strong footing in the market.

RT002 (daxibotulinumtoxin A)

RT002 is still undergoing trials and is yet to be approved. It is manufactured by Revance. The trials are expected to be completed in 2020. Revance is planning to introduce the product into the market in 2020 if it is approved.

BENEFITS and DRAWBACKS

The benefits and drawbacks of RT002 have not been published. This is expected as the product has not been approved.

PROJECTED MARKET IMPACT

The potential duration of RT002 for glabellar lines is six months due to the presence of a new neuromodulator that lasts longer. This longer timeframe is an advantage compared to around three months of Jeuveau and Botox since patients would prefer fewer visits to the clinic.

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