Synergy also received a boost when its chief competitor, Ironwood Pharmaceuticals (IRWD) received a setback at the FDA that allows SGYP an extra three months to play catch up in the race to commercialization for each company's respective product candidate, both of which target the same indication. Synergy's product Plecanatide, however, has a much more favorable side effect profile, making the Ironwood setback that much more of a key factor when discussing future market potential.
Both products, Synergy's Plecanatide and Ironwood's Linaclotide, are being developed to treat chronic idiopathic constipation (CIC) and constipation-predominant irritable bowel syndrome (IBS-C). Linaclotide is already before the FDA for review, although the review was delayed by three months, as mentioned before, while Phase II/III Plecanatide results are due out later this year.
The head start to market may provide Ironwood with a distinct advantage, but the advantage might not last too long when Plecanatide shows up on the scene.
During the Linaclotide trials, the drug was successful in alleviating symptoms relating to IBS-C and CIC when compared to a placebo, but the kicker is that patients experienced side effects that included cases of extreme diarrhea, essentially reversing the symptom being treated. Some cases of diarrhea were so bad that 6% of the patients decided to abandon the trial altogether.
On the open market - with a competing product out there for which there have been no such cases noted - that means those patients would likely switch to the alternative, in this case Plecanatide, that is not associated with carrying around a roll of Charmin' Soft at all times.
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