Delving into the Latest Updates on Triamcinolone hexacetonide/Sodium Hyaluronate with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Cingal, Hyaluronic acid/triamcinolone, Sodium hyaluronate/triamcinolone hexacetonide

+ [2]

Target

GR

Mechanism

GR agonists(Glucocorticoid receptor agonists)

Therapeutic Areas

Immune System DiseasesSkin and Musculoskeletal Diseases

Active Indication

Osteoarthritis

Inactive Indication

Osteoarthritis, Knee

Originator Organization

Anika International Ltd.

Active Organization

Anika Therapeutics, Inc.

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

CA (03 Nov 2015),

Osteoarthritis

Regulation-

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Structure

Molecular FormulaC30H41FO7

InChIKeyTZIZWYVVGLXXFV-FLRHRWPCSA-N

CAS Registry5611-51-8

Objective: To evaluate the efficacy and safety of an intraarticular injection of Cingal (Anika Therapeutics, Inc., Bedford, MA) compared with Monovisc (Anika Therapeutics, Inc., Bedford, MA) or saline for the treatment of knee osteoarthritis. Design: This multicenter, double-blind, saline-controlled clinical trial randomized subjects with knee osteoarthritis (Kellgren-Lawrence grades I-III) to a single injection of Cingal (4 mL, 88 mg hyaluronic acid [HA] plus 18 mg triamcinolone hexacetonide [TH]), Monovisc (4 mL, 88 mg HA), or saline (4 mL, 0.9%). The primary efficacy outcome was change in WOMAC (Western Ontario and McMaster Universities Arthritis Index) Pain Score through 12 weeks with Cingal versus saline. Secondary outcomes included Patient and Evaluator Global Assessments, OMERACT-OARSI Responder index, and WOMAC Total, Stiffness, and Physical Function scores through 26 weeks. Results: A total of 368 patients were treated (Cingal, n = 149; Monovisc, n = 150; saline, n = 69). Cingal improvement from baseline was significantly greater than saline through 12 weeks ( P = 0.0099) and 26 weeks ( P = 0.0072). WOMAC Pain was reduced by 70% at 12 weeks and by 72% at 26 weeks with Cingal. Significant improvements were found in most secondary endpoints for pain and function at most time points through 26 weeks. At 1 and 3 weeks, Cingal was significantly better than Monovisc for most endpoints; Cingal and Monovisc were similar from 6 weeks through 26 weeks. A low incidence of related adverse events was reported. Conclusions: Cingal provides immediate and long-term relief of osteoarthritis-related pain, stiffness, and function, significant through 26 weeks compared to saline. Cingal had similar immediate advantages compared with HA alone, while showing benefit comparable to HA at 6 weeks and beyond.

01 Jan 2008·American Journal of NeuroradiologyQ2 · MEDICINE

Evaluation of a Neck-Bridge Device to Assist Endovascular Treatment of Wide-Neck Aneurysms of the Anterior Circulation

Q2 · MEDICINE

Article

Author: Defreyne, L ; De Keukeleire, K ; Vanlangenhove, P

BACKGROUND AND PURPOSEIntracranial aneurysms with a wide-neck or an unfavorable dome-to-neck ratio may be difficult to treat properly and safely. Our aim was to evaluate the TriSpan neck-bridge device to assist coiling of wide-neck bifurcation aneurysms in the anterior circulation.MATERIALS AND METHODSIn 14 patients, we performed 16 TriSpan-assisted coil embolizations with wide-neck bifurcation aneurysms of the anterior circulation. Eleven procedures were indicated for acutely ruptured aneurysms. Five were performed electively for the following: recurrent aneurysm after coil only (n = 1) or after TriSpan-assisted embolization (n = 2), aneurysm remnant after clipping (n = 1), and aneurysm incidentally found (n = 1). Procedural and clinical complications were recorded. Follow-up angiography was performed, and clinical outcomes were assessed by using the modified Rankin Scale score.RESULTSTriSpan-assisted embolization was successful in 15/16 (93.8%) procedures, with complete occlusion in 2/16 (12.5%), near-complete occlusion in 10/16 (62.5%), and incomplete occlusion in 3/16 (18.75%). There were 6 (37.5%) intraprocedural complications: thrombus formation (n = 3), protrusion of a TriSpan loop in the parent artery (n = 1), TriSpan displacement in the aneurysm (n = 1), and tangling of a coil loop in the device (n = 1). Three patients died in the hospital (21.4%). Follow-up angiography or MR angiography was available in 8 (57.1%) patients and showed complete (n = 2), near-complete (n = 2), and incomplete occlusion (n = 4). Long-term clinical outcome was no (n = 4) or minor symptoms (n = 1) and moderate (n = 2), moderately severe (n = 2), or severe handicap (n = 2).CONCLUSIONThe use of the TriSpan device is feasible in the anterior circulation and can assist treatment of difficult wide-neck bifurcation aneurysms.

1

News (Medical) associated with Triamcinolone hexacetonide/Sodium Hyaluronate

16 Jan 2019

·www.biospace.com

Anika Announces Plans to Showcase HYALOFAST at the International Cartilage Regeneration and Joint Preservation Society (ICRS) Summit in San Diego

Jan. 16, 2019 21:05 UTC BEDFORD, Mass.--(BUSINESS WIRE)-- Anika Therapeutics, Inc. (NASDAQ: ANIK), a global, integrated orthopedic and regenerative medicines company specializing in therapeutics based on its proprietary hyaluronic acid ("HA") technology, today announced plans to showcase HYALOFAST, a biodegradable, HA-based cartilage repair scaffold, at the 2019 International Cartilage Repair Society (ICRS) Summit. The 2019 ICRS Summit, which will be focused on Bio-Orthopaedics in Sports Medicine, will be held in San Diego, CA at the Hyatt Regency Mission Bay on January 17-18, 2019. At the 2019 ICRS Summit, Dr. Alberto Gobbi, world-renowned specialist in arthroscopic surgery, cartilage repair and regenerative medicine, will present findings from a 10-year follow-up study of patients treated with HYALOFAST HA scaffold with Bone Marrow Aspirate Concentrate (BMAC) in a one-step surgery. The session will also provide a comparative review of HYALOFAST in comparison to ACI (Autologous Chondrocyte Implantation) and MACI (Matrix Autologous Chondrocyte Implantation), two-step surgeries requiring cell cultivation. “The ICRS Summit in San Diego is a great opportunity to showcase the significant advantages of HYALOFAST before an assembly of world-renowned specialists in the field of cartilage repair and regeneration,” said Joseph Darling, President and CEO, Anika Therapeutics. “We believe that HYALOFAST is a truly remarkable advancement in the treatment of cartilage injuries and defects due to its flexible, minimally-invasive means of application and adaptive fit to individual patient needs.” HYALOFAST is a non-woven, single-step, off-the-shelf, biodegradable HA-based scaffold for hyaline-like cartilage regeneration to treat cartilage injuries and defects. HYALOFAST is commercially available in approximately 15 countries and has been used to successfully treat more than 15,000 patients internationally, with strong ten-year patient follow-up data. HYALOFAST is pending regulatory submission in the United States following its FastTRACK Phase III trial which is currently enrolling patients across the U.S. and Europe. Technical Session 3: Cartilage Title: “One or Two Steps: Long Term Results” Presenter: Dr. Alberto Gobbi, OASI Bioresearch Foundation, Milano – Italy Date/Time: January 17, 2019 at 10:45 – 11:40am Company-Sponsored Booth Anika will be a Gold Sponsor and will host a booth (#6), where it will showcase HYALOFAST. About ICRS The ICRS (International Cartilage Regeneration and Joint Preservation Society) is the main forum for international collaboration in cartilaginous tissue research that brings together basic scientists, clinical researchers, physicians and members of industry, engaged or interested in the field of articular biology, its genetic basis and regenerative medicine. It provides continuing education and training to physicians and scientists with an active interest in the prevention and treatment of joint disease to improve patient care through regenerative medicine approaches. 2018 HYALOFAST Publications Gobbi A., et al. Use of bone marrow aspirate concentrate combined with hyaluronan-based scaffold for early osteoarthritis in athletes. Football Medicine Outcomes Abstract book XXVII Isokinetic Medical Group International Conference – Camp Nou, Barcelona 2-4 June 2018. Ed Calzetti & Mariucci. Page 442. Sofu H. et al. Clinical and radiographic outcomes of chitosan-glycerol phosphate/blood implant are similar with hyaluronic acid-based cell-free scaffold in the treatment of focal osteochondral lesions of the knee joint. Knee Surg Sports Traumatol Arthrosc. 2018 Aug 1. (Epub ahead of print). Gollwitzer H. Operative Therapie - Knorpelschäden der Hϋfte Einzeitiges arthroskopisches Verfahren zur Regeneration. Sportärztezeitung 03/2018 (Cartilage Damage to the Hip. One-Stage Arthroscopic Method of Regeneration). About Anika Therapeutics, Inc. Anika Therapeutics, Inc. (NASDAQ: ANIK) is a global, integrated orthopedic and regenerative medicines company based in Bedford, Massachusetts. Anika is committed to improving the lives of patients with degenerative orthopedic diseases and traumatic conditions with clinically meaningful therapies along the continuum of care, from palliative pain management to regenerative tissue repair. The Company has over two decades of global expertise developing, manufacturing, and commercializing more than 20 products based on its proprietary hyaluronic acid (HA) technology. Anika's orthopedic medicine portfolio includes ORTHOVISC®, MONOVISC®, and CINGAL®, which alleviate pain and restore joint function by replenishing depleted HA, and HYALOFAST, a solid HA-based scaffold to aid cartilage repair and regeneration. For more information about Anika, please visit .

100 Deals associated with Triamcinolone hexacetonide/Sodium Hyaluronate

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External Link

KEGG	Wiki	ATC	Drug Bank
-	-	H02AB08	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Osteoarthritis	CA	Anika Therapeutics, Inc.	03 Nov 2015

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Osteoarthritis	Discovery	US	Anika Therapeutics, Inc.	22 May 2017
Osteoarthritis, Knee	Discovery	HU	Anika Therapeutics, Inc.	01 Feb 2015
Osteoarthritis, Knee	Discovery	CZ	Anika Therapeutics, Inc.	01 Feb 2015
Osteoarthritis, Knee	Discovery	PL	Anika Therapeutics, Inc.	01 Feb 2015

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04231318 (CTgov)	Phase 3	Osteoarthritis, Knee	231	Cingal (Cingal)	htxmadigfm(jhcdrthedz) = yiwujnkrox ofguqxdyva (hmisbzzhma, wklrbxrsup - pftoiidxyx) View more	-	09 Aug 2023
				Triamcinolone Hexacetonide (TH) (Triamcinolone Hexacetonide (TH))	htxmadigfm(jhcdrthedz) = trttezsvij ofguqxdyva (hmisbzzhma, lhsrunqwgd - fkmmoshrhr) View more
NCT03390036 (Cingal17-02, CTgov)	Phase 3	Osteoarthritis, Knee	526	Cingal (Cingal)	aizfxymwus(bzyeyhmxde) = thlwtpnbzm zthuhwkzcg (epbhsuvopg, lbkgnptlss - rjkxijwmgr) View more	-	31 May 2023
				Monovisc (Monovisc)	aizfxymwus(bzyeyhmxde) = trcqknitlg zthuhwkzcg (epbhsuvopg, pcbavibftg - ierpyqwsst) View more
NCT03191903 (CTgov)	Phase 3	Osteoarthritis, Knee	576	Cingal (Cingal)	ftkaxuhmhe(yqknhgnfkt) = qqzfziuhqg jzkymrrfoa (wpufclknor, ugmkjpupnr - pufnkatrha) View more	-	24 Feb 2022
				Monovisc (Monovisc)	ftkaxuhmhe(yqknhgnfkt) = pskqajmbhl jzkymrrfoa (wpufclknor, xqdujnloar - gsgkcbgibs) View more
NCT02381652 (CTgov)	Phase 3	Osteoarthritis, Knee	242	Cingal (Cingal/Cingal)	fblujcnlrf(hphdbuozgv) = luzyltscqm gtyzjsvozb (phnrqsdrrw, loccmdnfxd - uxljuksotk) View more	-	03 Sep 2020
				Cingal (Cingal/Monovisc)	fblujcnlrf(hphdbuozgv) = iseedkkbon gtyzjsvozb (phnrqsdrrw, kkxlptfyzn - czykbdnwfx) View more
Pubmed \| Cartilage	Not Applicable	Osteoarthritis, Knee	368	Cingal (4 mL, 88 mg hyaluronic acid [HA] plus 18 mg triamcinolone hexacetonide [TH])	tcrihakghq(rcewcgaqkp) = omzqkhruwi vytavvfpcu (vwdzgampkg )	Positive	01 Jul 2018