We are warned not just listen to one side of the story. The same advice applies when you digest the biotech news. This August, Adamas made headline because its drug Gocovri gained the FDA’s first approval to treat levodopa-induced dyskinesia, an involuntary movement disorder occurred in 90% of the levodopa-treated Parkinson patients.
Do you think it is another major medical advancement to the bedside of patients with Parkinson’s disease? Did it make you smile big when you pop open the news?
Yes, it did make my heart sing when I read the following news!
News source 1: REUTERS
It reports that Gocovri is “the first drug cleared by the FDA to control levodopa-induced dyskinesia.” The pill is taken once-daily at bedtime. It also targets off time (refers to periods of the day when the medication is not working well, causing worsening of Parkinsonian symptoms), so patients gain additional 3.6 hours of functional time every day.
HOWEVER, my excitement was a short-lived one, because another news popped up…
News source 2: ENDPOINTS
It has been candid that Gocovri, an “extended-release version,” is a tweaked generic version amantadine, which already had an off-label use for dyskinesia. Then it pointed out that Gocovri’s list annual price is $10K – $30K, while the original generic version is $2/100mg. It might not say anything about price difference by simply comparing this way. Based on my research, 274 mg daily is recommended for Gocovri, and 600 mg is the maximal daily consumption for the generic version. Therefore, the generic drug would cost each patient $4380 at the most! However, the article ended on a high note with Adama’s two successful phase III clinical trials.
News source 3: BioPharma DIVE
This article is injected with details, combining essentials from both Reuters and Endpoints news. It praised the drug for being “first-of-its-kind”. It also highlighted the success of the clinical trial by illustrating both dyskinesia reduction rate and gained functional time. In addition, it compared the proposed price of Gocovri’s to other competitor drugs on the market, ranging from $25K – $60K. In this way, the $10K – $30K doesn’t seem too unreasonable. The report also revealed that Adamas’ ambition of reaching 95% neurologists.
News source 4: FDA – RF Regulatory Focus
Apparently, FDA is not interested in judging. It includes both Endpoints and Reuters news links on their website.
Interestingly, none of the resources touched on the topic what extended-release drug is. By digging deeper into the capsule inactive ingredient of Gocovri, I found the formula contains both hydrophilic polymers (HPC) and diffusion-controlling membranes (ethylcellulose). Gocovri can be taken with and without food, which means no worries of the risk of dose-dumping. Amazing! The complicated patent strategy and science behind extended-release drug can be a topic for another day.
One side of the story. Create bias.
Many sides of the story. Unfold an entire maze.