LegalReader.com  ·  Legal News, Analysis, & Commentary

HISTORY ARCHIVE

Psoriasis Drug Gastrointestinal Side Effects Outweigh Usefulness


— September 16, 2015

XenoPort is developing a new psoriasis drug but has hit some snags. During patient trials, one-third of the study participants dropped out due to severe gastrointestinal side effects involving diarrhea.


A psoriasis drug by XenoPort, Inc. may be a medication that does more harm than good. The drug, XP23829, got poor marks in a mid-stage study. According to the data the psoriasis drug gastrointestinal side effects outweigh usefulness.

Psoriasis affects 2.0 to 2.6% of the U.S. population, making it one of the most common autoimmune diseases. It causes sore or itchy patches of this, red skin with silver scales and it is difficult to treat. Roughly 15% of psoriasis patients could develop psoriatic arthritis. XenoPort claims that both the 400mg and 800mg doses alleviated some of the symptoms.

1049-image-1377134469

However, during XP23829’s trial in psoriasis patients, 22-40% of the drug group complained of adverse diarrhea- related events. The placebo group reported on 15%, according to XenoPort. Gastrointestinal upset, such as abdominal pain, nausea & vomiting were the most common side effects.

Analyst, Eric Schmidt of Cohen Co., commented that pursuing XP23829 is a poor use of limited resources on XenoPort’s part. The drug actually seems to be inferior to the standard of care for treating psoriasis. XP23829 didn’t measure up to Celegene Corp’s Otezla (FDA approved 2014) and Biogen Inc’s Tecfidera for multiple sclerosis. XenoPort has other ideas, though. The company plans to start late-stage trials in 2016, as well as searching for partnerships to accelerate XP23829’s global development.

It may pay to be optimistic, but I don’t think that’s the case here. XenoPort announced on a conference call that the severity of the gastrointestinal side effects resulted in one-third of the drug study’s participants dropping out. The company’s shares fell 25%, hitting an all-year low of $5 in mid-day trade on the Nasdaq. Premarket, XenoPort’s shares had risen as high at 19%.

Earlier this year, the FDA granted approval to Novartis for its injectable psoriasis drug, Cosentyx. Eli Lilly & Co is working on Ixekizumab, also for psoriasis. In addition, Valeant Pharmaceuticals International, Inc in Canada purchased rights to brodalumab, a late-stage psoriasis drug from AstraZeneca. Amgen Inc dropped brodalumab in May.

Source:

XenoPort’s psoriasis drug shows higher side effects; shares fall

 

Join the conversation!