Biotech Catalyst Play: Flexion Therapeutics Inc (NASDAQ:FLXN)

Over the past 12 months here at Insider Financial, we have highlighted a number of opportunities in the biotechnology sector as part of our Biotech Catalyst series.Essentially, we try to alert our readers as to certain biotechnology catalysts before they hit press so as that anybody looking to pick up an exposure to the catalyst in question can do so before wider markets and, most importantly, before the move it brings about in the stock price of the company in question. FLXN Daily ChartA large number of these opportunities have played out in our favor and, by proxy, have resulted in substantial returns for our readers that acted on the information.We are now heading into the final quarter of the year and we've got one more for you.The company in question is Flexion Therapeutics Inc (NASDAQ:FLXN) and the catalyst relates to its lead development asset, a drug called Zilretta.By way of a bit of background, Flexion doesn't have any drugs on the market right now, meaning, if it can get Zilretta past the FDA in the US, it would be the company's first commercially available drug. It's a pain management asset and, initially, it's targeting patients with osteoarthritis (OA) of the knee.This is a target indication for which there are already quite a few treatment options available, so why does Flexion think it can make any money by bringing a fresh alternative to the table?Well, the standard of care therapy in this indication is regular corticosteroid injections or, as an alternative, a prescription opioid. There is an ongoing opioid epidemic in the US right now and the FDA is trying to tackle it by fast-tracking non-opioid-based treatments. A corticosteroid injection is one such treatment, but for a chronic condition like osteoarthritis of the knee, the number of steroid injections required makes for a costly and unpleasant treatment experience for the patient.So, with Zilretta, Flexion has taken an already well-established corticosteroid called triamcinolone acetonide and applied a proprietary microbead technology to it in an attempt to transform it into an extended release asset.The idea is, then, that a patient can go to a healthcare facility, get one injection of the extended-release formulation (Zilretta) and then not need have to have another administration for weeks or months, depending on the severity of the osteoarthritis in question.As compared to the daily injections often required for patients in this indication, or the potentially addictive opioid therapies, a drug like Zilretta (if it picks up approval) could be a game changer.The data that underpins the NDA application that is with the FDA right now is strong, having showed that Zilretta demonstrated a highly significant (p<0.0001) reduction in average daily pain versus placebo at week 12 (this was the primary endpoint), with durable and clinically meaningful pain relief in patients with moderate to severe OA knee pain. Additionally, the most common adverse events in the active arm were arthralgia, headache, joint swelling and back pain, none of which should raise any alarms at the FDA.So with a strong efficacy data set and a relatively clean safety profile, there is a great chance that this drug will pick up approval when it goes in front of the FDA.Combine this with a more than $800 million peak sales estimate and the fact that Sanofi SA (ADR) (NYSE:SNY) was rumored to be interested in buying Flexion (for Zilretta) earlier this year before the former's VP and Global Head of Medical for Rare Diseases, Yamo Deniz, jumped ship and joined Flexion as CMO, and you've got the potential for some real action come PDUFA.So when is the date to watch?This one is a near-term action date, with Flexion's PDUFA slated for October 6, 2017.We will be updating our subscribers as soon as we know more. For the latest updates on FLXN, sign up below!Image courtesy of Dave Haygarth via FlickrDisclosure: We have no position in FLXN and have not been compensated for this article.