Delving into the Latest Updates on Trafermin with Synapse

Overview

Basic Info

Drug Type

Growth factors

Synonyms

Fiblast Spray, REGROTH Dental Kit, RH-BFGF

+ [11]

Target

FGFRs

Action

stimulants

Mechanism

FGFRs stimulants(Fibroblast growth factor receptors stimulants)

Therapeutic Areas

Mouth and Tooth DiseasesSkin and Musculoskeletal Diseases

Active Indication

PeriodontitisPressure UlcerSkin Ulcer

Inactive Indication

Alveolar Bone LossDiabetic foot ulcerPeriodontal Attachment Loss

Originator Organization

Kaken Pharmaceutical Co., Ltd.

Active Organization

Kaken Pharmaceutical Co., Ltd.

Inactive Organization

Olympus Biotech Corp.

Drug Highest PhaseApproved

First Approval Date

Japan (04 Apr 2001),

Pressure UlcerSkin Ulcer

Regulation-

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Structure/Sequence

Sequence Code 507553

Source: *****

OBJECTIVETo identify factors correlated with the effect of intracordal trafermin injection.STUDY DESIGNRetrospective cohort study.METHODSHerein, 177 patients who received an intracordal trafermin injection at the Tokyo Voice Center for vocal fold paralysis were included. Medical records of patients were retrospectively reviewed. Information regarding age, sex, date of trafermin injection, date of vocal fold paralysis onset, and voice data indices [maximum phonation time (MPT), pitch range (PR), mean flow rate (MFR), and Voice Handicap Index (VHI)] was extracted. The primary endpoint was the rate of improvement in the VHI, defined as the difference in the VHI values before and after the injection.RESULTSA total of 80 patients (49 men and 31 women; mean age, 61.6 years) were included. No correlations existed between the MPT (r = 0.05, P = 0.64), PR (r = 0.03, P = 0.77), or MFR (r = -0.09, P = 0.42) before injection and the rate of improvement in the VHI. Analyses of 74 cases with an interval of <1000 days between disease onset and injection revealed no correlation between the number of days from the onset to injection and the rate of improvement in the VHI. In 17 cases with an interval of <90 days, a moderate negative correlation existed between these parameters (r = -0.59, P < 0.01). In a univariate linear regression analysis, within 90 days, a 1-week delay in trafermin injection resulted in a 4.87 decrease in the VHI.CONCLUSIONSIntracordal trafermin injection may be an effective therapeutic strategy for severe vocal fold paralysis, with a particularly high efficacy when performed early after paralysis onset. In patients undergoing aortic surgery, intracordal trafermin injection post surgery and before extubation may prevent or reduce postoperative voice disorders caused by vocal fold paralysis due to recurrent nerve palsy and prevent postoperative pulmonary complications.

01 Mar 2024·American Journal of Otolaryngology

Effects of intracordal trafermin injection on mutational voice disorder

Author: Watanabe, Yusuke ; Hasegawa, Tomohiro

INTRODUCTIONMutational voice disorder is the inability of the voice to adjust to the changes in the larynx during puberty, resulting in the speaking fundamental frequency failing to decrease. Standard treatments for mutational voice disorder are voice therapy and thyroplasty. However, voice therapy takes time to show its effects, and thyroplasty is highly invasive. Herein, we present a case of mutational voice disorder successfully treated with intracordal trafermin injection.CASE SUMMARYA 31-year-old male patient was diagnosed with mutational voice disorder and offered standard treatment, but he requested a less invasive treatment with early effects. We performed intracordal trafermin injection with his consent. Two months after the procedure, the speaking fundamental frequency decreased from 155.5 Hz to 93.0 Hz, and the voice handicap index decreased from 14 to 2.DISCUSSIONThis case suggests that intracordal trafermin injection is an effective treatment option for mutational voice disorder. Furthermore, compared with the standard treatment methods, it is less invasive and provides effects shortly with only one injection.

25 Jan 2024·Zhongguo gu shang = China journal of orthopaedics and traumatology

[Application value of bone cement containing rhbFGF and RHBMP-2 in PKP treatment of osteoporotic lumbar compression fracture].

Article

Author: Liu, Qiong ; Chen, Jia-Ru ; Zhang, Rong ; Xia, Yu-Dong

OBJECTIVETo investigate the effect of bone cement containing recombinant human basic fibroblast growth factor (rhbFGF) and recombinant human bone morphogenetic protein-2 (rhBMP-2) in percutaneous kyphoplasty(PKP)treatment of osteoporotic vertebral compression fracture(OVCF).METHODSA total of 103 OVCF patients who underwent PKP from January 2018 to January 2021 were retrospectively analyzed, including 40 males and 63 females, aged from 61 to 78 years old with an average of (65.72±3.29) years old. The injury mechanism included slipping 33 patients, falling 42 patients, and lifting injury 28 patients. The patients were divided into three groups according to the filling of bone cement. Calcium phosphate consisted of 34 patients, aged(65.1±3.3) years old, 14 males and 20 females, who were filled with calcium phosphate bone cement. rhBMP-2 consisted of 34 patients, aged (64.8±3.2) years old, 12 males and 22 females, who were filled with bone cement containing rhBMP-2. And rhbFGF+rhBMP-2 consisted of 35 patients, aged (65.1±3.6) years old, 14 males and 21 females, who were filled with bone cement containing rhbFGF and rhBMP-2. Oswestry disability index (ODI), bone mineral density, anterior edge loss height, anterior edge compression rate of injured vertebra, visual analog scale (VAS) of pain, and the incidence of refracture were compared between groups.RESULTSAll patients were followed for 12 months. Postoperative ODI and VAS score of the three groups decreased (P<0.001), while bone mineral density increased (P<0.001), anterior edge loss height, anterior edge compression rate of injured vertebra decreased first and then slowly increased (P<0.001). ODI and VAS of group calcium phosphate after 1 months, 6 months, 12 months were lower than that of rhBMP-2 and group rhbFGF+rhBMP-2(P<0.05), bone mineral density after 6 months, 12 months was higher than that of rhBMP-2 and group calcium phosphate(P<0.05), and anterior edge loss height, anterior edge compression rate of injured vertebra of group rhbFGF+rhBMP-2 after 6 months and 12 months were lower than that of group rhBMP-2 and group calcium phosphate(P<0.05). There was no statistical difference in the incidence of re-fracture among the three groups (P>0.05).CONCLUSIONBone cement containing rhbFGF and rhBMP-2 could more effectively increase bone mineral density in patients with OVCF, obtain satisfactory clinical and radiological effects after operation, and significantly improve clinical symptoms.

100 Deals associated with Trafermin

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External Link

KEGG	Wiki	ATC	Drug Bank
D03362	Trafermin	D03	DB06244

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Periodontitis	Japan	Kaken Pharmaceutical Co., Ltd.	28 Sep 2016
Pressure Ulcer	Japan	Kaken Pharmaceutical Co., Ltd.	04 Apr 2001
Skin Ulcer	Japan	Kaken Pharmaceutical Co., Ltd.	04 Apr 2001

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Diabetic foot ulcer	Preclinical	Czechia	Olympus Biotech Corp.	01 Nov 2010
Diabetic foot ulcer	Preclinical	Italy	Olympus Biotech Corp.	01 Nov 2010
Diabetic foot ulcer	Preclinical	France	Olympus Biotech Corp.	01 Nov 2010
Diabetic foot ulcer	Preclinical	Hungary	Olympus Biotech Corp.	01 Nov 2010
Alveolar Bone Loss	Preclinical	Japan	Kaken Pharmaceutical Co., Ltd.	01 Aug 2008
Periodontal Attachment Loss	Preclinical	Japan	Kaken Pharmaceutical Co., Ltd.	01 Aug 2008

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01217463 (TRANS-South, CTgov)	Phase 3	Diabetic foot ulcer	201	Trafermin 0.01% spray (Trafermin 0.01% Spray)	nizaggfwgv(zubmnlgkik) = utrkpvstcq pwdrgjsiro (zfnlwqzcjg, vudgpjdmtt - yzytikasma)	-	05 Aug 2014
				Trafermin 0.01% spray (Matching Placebo Spray)	nizaggfwgv(zubmnlgkik) = qnprdouzzc pwdrgjsiro (zfnlwqzcjg, gazcqsqxyd - qztcdvyxkp)
NCT01217476 (TRANS-North, CTgov)	Phase 3	Diabetic foot ulcer	207	Trafermin (Trafermin)	iywugvmofj(vfisugjdcg) = bcqgrsyggp dzgiqwkwjd (ijliabiabm, pxmhbzzjrp - kracklgwgs) View more	-	05 Aug 2014
				placebo (Placebo)	iywugvmofj(vfisugjdcg) = rsazqnwpum dzgiqwkwjd (ijliabiabm, cmkyjfgqwz - iudxnqryca) View more
ARVO2003	Not Applicable	Ganglion Cysts	-	Adenosine 10 µM	urrtynlcvl(ueicylzkpk) = qotzerxfnv niwafcezox (wcixdfwezj )	-	01 May 2003
				Adenosine 100 µM	urrtynlcvl(ueicylzkpk) = svyvjidcer niwafcezox (wcixdfwezj )
ARVO2002	Not Applicable	Neovascularization, Pathologic	18	Medpor(R) soaked with bFGF	votdmoqmjh(udmrtreggu) = cengsoxivx wkbekqfvlr (mtrusplmre )	Positive	01 Dec 2002
				Basic Fibroblast Growth Factor (Unsoaked Medpor(R))	votdmoqmjh(udmrtreggu) = zfhxkcfjrh wkbekqfvlr (mtrusplmre )

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Biosimilar

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