新药Seysara（sarecycline）片是40年来首个皮肤病口服抗生素，该药的上市，将为中度至重度痤疮患者提供一种创新的治疗选择。
近日，FDA批准Seysara（sarecycline）片的上市，用于9岁及以上中度至重度非结节性炎症性寻常痤疮患者的治疗。
Seysara是一种首创（first-in-class）、窄谱四环素衍生抗生素，具有抗炎作用，该药每日口服一次，可与食物或不与食物同服，在临床研究中已被证明在开始用药后3周内可使皮肤炎性病变实现统计学意义的显著改善减少，并且具有良好的安全性和耐受性。 
批准日期：2017年12月21日 公司：Allergan
SEYSARA（sarecycline）片剂用于口服。
美国最初批准：2018年
作用机制
SEYSARA治疗寻常痤疮的作用机制尚不清楚。
适应症和用法
SEYSARA™是一种四环素类药物，用于治疗9岁及以上的非结节性中度至重度寻常痤疮的炎症性病变。
使用限制
SEYSARA超过12周的功效和超过12个月的安全性尚未确定。SEYSARA尚未对感染治疗进行评估。为减少耐药细菌的发展以及维持其他抗菌药物的有效性，SEYSARA应仅按照指示使用[见警告和注意事项]。
剂量和给药
SEYSARA的推荐剂量是每日一次，有或没有食物：
•体重33-54公斤的患者60毫克，
•对于体重55-84千克的患者，100毫克，
•对于体重85-136千克的患者，150毫克。
剂量形式和强度
片剂：60mg，100mg，150mg
禁忌症
SEYSARA禁用于对四环素过敏的人。
警告和注意事项
•SEYSARA在牙齿发育过程中的使用（妊娠，婴儿和儿童直至8岁的第二和第三季）可能导致牙齿永久性变色（黄灰棕色）。
•如果发生艰难梭菌相关性腹泻（抗生素相关性结肠炎），则停止使用SEYSARA。
•据报道，使用四环素可引起中枢神经系统副作用，包括头晕，头晕或眩晕。对于驾驶车辆或使用危险机械，应该警告出现这些症状的患者。这些症状可能会在治疗中消失，并可能在药物停用后消失。
•SEYSARA可能引起颅内高压。如果出现症状，请停止使用SEYSARA。
•SEYSARA可能会发生光敏感。患者应尽量减少oravoid暴露于自然或人造阳光下。
不良反应
最常见的不良反应（发生率≥1％）是恶心。要报告疑似不良反应，请致电1-800-678-1605联系Allergan或1-800-FDA-1088或www.fda.gov/medwatch联系FDA。
药物相互作用
•口服类视黄醇：避免共同给药。
•抗酸剂和铁制剂：SEYSARA的单独剂量。
•青霉素：避免共同给药。
•抗凝血剂：适当减少抗凝剂剂量。
•P-糖蛋白底物：监测可能需要减少剂量的药物的毒性。
用于特定人群
•与其他四环素类药物一样，Sarecycline可能会对孕妇造成胎儿伤害。
•在牙齿发育过程中使用四环素类药物可能导致牙齿永久性变色。
•哺乳期：不推荐母乳喂养。
包装提供/存储和处理
提供
1）SEYSARA（sarecycline）片剂，60mg为胶囊状，黄色薄膜包衣片，一面用“S60”压印，另一面用空白。
•30片装有儿童防护罩的药片：NDC：0023-6245-30
2）SEYSARA（sarecycline）片剂，100mg为胶囊状，黄色，薄膜包衣片，一面用“S100”压印，另一面用空白。
•30片装有儿童防护罩的药片：NDC：0023-6246-30
3）SEYSARA（sarecycline）片剂，150mg胶囊状，黄色薄膜包衣片，一面用“S150”压印，另一面用空白。
•30片装有儿童防护罩的药片：NDC：0023-6247-30
存储
储存在20°C - 25°C（68°F - 77°F）; 允许偏移15°C - 30°C（59°F - 86°F）[参见USP ControlledRoom Temperature]。
处理
防止受潮和过热。
FDA Approves Seysara(sarecycline) for the Treatment of Moderate to Severe Acne
FDAhas approved Seysara(sarecycline), a new, innovative first in class tetracycline-derived oral antibiotic for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older.
Seysara is an oral tablet that is taken once daily with or without food. It has proven significant reduction of inflammatory lesions as early as three weeks after start of the treatment and is generally safe and well tolerated. Seysara represents an innovative treatment for patients with moderate to severe acne.
Peter Guenter, Chief Executive Officer, Almirall, commented "We are proud to have obtained the FDA's approval for Seysara, which will bring a new option for the many patients with unmet medical needs. It brings a major launch opportunity for Almirall in the US of an innovative first-in-class treatment for moderate to severe acne.
Dr Leon Kircik, a leading US dermatologist from Louisville, Kentucky and a sarecycline clinical trialist, added "As dermatologists we are always seeking ways to improve the management of our patients' disease. The results of the studies are encouraging, with statistically significant efficacy vs placebo as early as 3 weeks. I'm looking forward to having this as an option for my patients when it becomes available in 2019.
Acne vulgaris is a common chronic skin disease involving blockage and/or inflammation of pilosebaceous units (hair follicles and their accompanying sebaceous gland). Acne can present as non-inflammatory lesions, inflammatory lesions, or a mixture of both, affecting mostly the face but also the back and chest. According to the Global Burden of Disease (GBD) study, acne vulgaris affects 85% of young adults aged 12–25 years globally. It affects 80% of Americans at some time during their lives. Of these percentages of affected Americans, 20% have severe acne, which can result in permanent physical and mental scarring.
About Seysara
Seysara (sarecycline) is a once-daily, oral tetracycline-derived antibiotic with anti-inflammatory properties for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older. Seysara has proven to be a safe and effective treatment in two 12-week multicenter, randomized, double-blind, placebo-controlled studies(Study 1[NCT02320149] and Study 2[NCT02322866]).Efficacy was assessed in a total of 2002 subjects 9 years of age and older.
Important Safety Information
Efficacy of Seysara beyond 12 weeks and safety beyond 12 months have not been established. Seysara has not been eva luated in the treatment of infections.To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, Seysara should be used only as indicated. Seysara is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines. The use of Seysara during tooth development may cause permanent discoloration of the teeth. If Clostridium difficile associated diarrhea (antibiotic associated colitis) or intracranial hypertension occurs, discontinue Seysara. Central nervous system side effects, including light-headedness, dizziness or vertigo, have been reported with tetracycline use. Most common adverse reaction (incidence≥1%) is nausea.
Complete data attachment:https://www.accessdata.fda.gov
/drugsatfda_docs/label/2018/209521s000lbl.pdf