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right knee osteoarthritis icd 10
Flexion Therapeutics (NASDAQ: FLXN) is about to acquisition out if its analysis efforts will pay off. The U.S. Food and Biologic Administration is accepted to affair a go/no-go accommodation on its analysis for osteoarthritis affliction of the knee -- Zilretta -- on Oct. 6, and because Zilretta is the company's abutting biologic to commercialization, the regulators' accommodation could actualize a agrarian beat college or lower in the company's banal price. Is this aggregation about to become the accepted of affliction or will the FDA accord Zilretta a red light?
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Is this aggregation about to become the accepted of affliction or will the FDA accord Zilretta a red light?
A big bazaar befalling
Flexion Therapeutics thinks anniversary Zilretta injections can bear greater affliction abatement for osteoarthritis of the knee patients than corticosteroids. Results from one appearance 3 balloon advance that's true.
IMAGE SOURCE: GETTY IMAGES.
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Currently, about 5 actor Americans accept anniversary corticosteroid shots, but these shots action bare abatement for many. Affliction abridgement can activate to abate alone a few weeks afterwards injection, and generally the account of the analysis has abolished altogether above-mentioned to the abutting appointed dose. As a result, patients may access their use of accomplishment affliction relievers, including opioids.
Zilretta is an extended-release conception of a long-used, short-acting corticosteroid alleged triamcinolone acetonide. Flexion Therapeutics uses a proprietary microsphere technology to amalgamate the corticosteroid with a poly lactic-co-glycolic acid. The conception allows for a apathetic absolution of triamcinolone acetonide that appears to accommodate added acceptable affliction relief.
In trials, Zilretta bargain affliction in patients with osteoarthritis of the knee by a average 50% at the 12-week mark. If the biologic is approved, its ability and continuance of aftereffect may acquiesce it to alter the use of corticosteroid shots in millions of patients, abnormally back it could abate the charge for accomplishment drugs, including habit-forming ones.
Management suggests a amount of $500 per injection, or $2,000 annually, would be accurate by insurers. If so, again a big accommodating citizenry could about-face Zilretta into a nine-figure drug. For angle on the bazaar opportunity, Sanofi's Synvisc-One, a hyaluronan bang for knee pain, produces about $400 actor in anniversary revenue.
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Risks abide
There are about 14 actor bodies who ache from osteoarthritis of the knee, and almost 40% of osteoarthritis patients are assigned analgesic affliction relievers. Given the big charge for analysis alternatives that could abate opioid prescriptions, Zilretta's solid ability and abeyant to abatement the charge for accomplishment drugs may position it accurately for a authoritative OK. In the past, the FDA has been articulate in auspicious the development of new affliction treatments, and that cold may angle its accommodation on Zilretta in favor of Flexion Therapeutics.
That said, there's no agreement that regulators will green-light Zilretta. They could ask for added abstracts to affirm its benefit, catechism manufacturing, or adios it outright. A bounce would acutely be bad account for Flexion Therapeutics' shareholders because Zilretta is the alone biologic in its pipeline.
Unquestionably, this makes affairs shares advanced of tomorrow's FDA accommodation a chancy proposition. An OK could ballista shares higher, decidedly back 27% of Flexion Therapeutics' allotment float is captivated short. Alternatively, a bounce would apparently account shares to crash. Overall, Flexion Therapeutics has a solid attempt at acceptable a Zilretta approval, but affairs its shares advanced of this accommodation may be too chancy for best investors.
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Todd Campbell owns shares of Flexion Therapeutics. His audience may accept positions in the companies mentioned. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a acknowledgment policy.
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