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The US Food and Drug Administration (FDA) has approved once-daily tretinoin 0.05% lotion (Altreno, Ortho Dermatologics) for treatment of acne vulgaris in patients aged 9 years and older, making it the first tretinoin product to be available in lotion form.

While topical retinoids have proven highly effective in treating acne, they may be associated with skin irritation, such as dryness and peeling, and sensitivity. "In clinical trials, Altreno lotion provided the proven efficacy of tretinoin, a retinoid, in a generally well-tolerated formulation with skin dryness, pain, swelling, irritation and peeling reported in ≤4% of patients," the company said in a news release.

Altreno was evaluated in two phase 3, double-blind, vehicle-controlled clinical trials involving a total of 1640 patients aged 9 years and older. In both studies, Altreno lotion resulted in statistically significant reductions in both inflammatory and noninflammatory lesions compared with vehicle.

At week 12, 16.5% and 19.8% of Altreno-treated patients in trials 1 and 2, respectively, achieved treatment success, defined as at least a 2-grade improvement in global severity by Evaluator Global Severity Scores (EGSS) and EGSS score of clear or almost clear, compared with 6.9% and 12.5% of patients treated with vehicle. Patient satisfaction and acne quality-of-life assessments also favored Altreno over vehicle at week 12.

 

The most common adverse reactions occurring in more than 1% of participants and greater than with vehicle were dryness, pain erythema, irritation, and exfoliation.

Sunscreen and protective clothing should be worn when sun exposure cannot be avoided. Altreno should be used with caution in patients who are allergic to fish because of potential for allergenicity to fish protein. Full prescribing information is available online.  

The company expects Altreno to be available later this year.

美國食品和藥物管理局(FDA)已批准Altreno(tretinoin,維甲酸,0.05%)乳液用於9歲及以上患者尋常痤瘡的局部治療。Altreno是首個乳液配方的維甲酸產品,Ortho公司預計將在今年第四季將Altreno推向市場。

用藥方面,Altreno每日一次局部塗抹,當日光照射不能避免時,患者應穿戴防曬工具和防護服

如果患者對魚肉過敏時,應謹慎使用Altreno。
Altreno獲得批准是基於一項III期臨床項目的數據。

該項目包括2個相同的多中心、隨機、雙盲、賦形劑對照III期研究,入組了1640例9歲及以上中度至重度尋常痤瘡患者,以評估該藥的有效性和安全性。

研究的共同主要終點包括:治療12周時痤瘡整體嚴重度評分(EGSS)成功率(定義為:相對基線改善≥2級且EGSS評分為清晰[0]或幾乎清晰[1])、非炎症性病變和炎症性病變計數的絕對變化。
研究結果顯示,與賦形劑相比,Altreno乳液使EGSS成功率顯著提高、炎症性和非炎症性面部病變顯著減少、患者滿意度顯著提高,而且一般耐受性良好。具體數據為:
(1)第一、二項研究數據顯示,在治療的第12周,與賦形劑組相比,Altreno治療組有更高比例的患者在EGSS方面取得成功分別為16.5% vs 6.9%,及19.8% vs 12.5%;非炎症性面部病變平均減少分別為47.5%(賦形劑組為27.3%),及45.%(賦形劑組為31.9%);炎症性面部病變平均減少50.9%(賦形劑組為40.4%),及53.4%(賦形劑組為41.5%)。
(2)數據還顯示,在治療的第12周,與賦形劑組相比,Altreno治療組患者滿意度(基於治療第12周完成的1396份調查)顯著提高:治療組滿意度提高53%,賦形劑組提高43%(p<0.001)。90%的患者報告對Altreno治療滿意。
(3)與賦形劑組相比,Altreno治療組平均痤瘡-生活質量(Acne-QoL)評估結果有統計學意義的顯著提高:平均得分相對基線的變化:自我感知(7.4 vs 6.7,p=0.003)、角色-情感(7.4 vs 6.7,p=0.003)、社會角色(4.8 vs 4.6,p=0.038)、痤瘡症狀(6.5 vs 5.6,p<0.001)。
(4)安全性方面,Altreno治療組發生率>1%且高於賦形劑組的最常見不良反應包括:皮膚乾燥、痛性紅斑、刺激和脫落。

 

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