目前，美国FDA批准了国际BioDelivery科学和Meda两公司共同开发的芬太尼（fentanyl）颊溶膜剂Onsolis，用于缓解≥18岁且已在接受阿片类药物治疗持续性癌痛或对阿片类药物呈耐量现象的肿瘤患者的爆发性癌痛。Onsolis以置于口颊黏膜上方式使用，几分钟内便会溶解并释出药物。药物经黏膜吸收，产生止痛作用。

ONSOLIS

Generic Name for ONSOLIS

Fentanyl (as citrate) 200mcg, 400mcg, 600mcg, 800mcg, 1200mcg; buccal soluble film.

Legal Classification:

CII

Pharmacological Class for ONSOLIS

Opioid.

Manufacturer of ONSOLIS

Meda Pharmaceuticals

Indications for ONSOLIS

Breakthrough pain, only in opioid-tolerant patients who are already receiving and are tolerant to continuous (not "as needed") opioid therapy for underlying persistent cancer pain. Opioid-tolerant patients are those taking oral morphine ≥60mg/day, transdermal fentanyl ≥25mcg/hr, oral oxycodone ≥30mg/day, oral hydromorphone ≥8mg/day, oral oxymorphone ≥25mg/day, or equianalgesic dose of another opioid for ≥1 week.

Adult dose for ONSOLIS

≥18yrs: Do not cut film. Place on moistened area inside cheek; wait at least 5min before drinking liquids, do not manipulate film or eat until film has dissolved. Titrate with 200mcg film(s) then switch to one film at the titrated dose. Initially 200mcg; titrate in 200mcg increments, up to max 4x200mcg films or one 1200mcg film. Max one dose/episode; no more than 4 doses/day at least 2hrs apart. If titrating above 4x200mcg films, switch to one 1200mcg film; max 1200mcg/dose. Do not convert from other fentanyl products on a mcg-mcg basis. Do not interchange with other fentanyl products. Do not put one film on top of another. May use another rescue drug 30min after film placement if needed.

Children's dosing for ONSOLIS

<18yrs: not recommended.

Contraindications for ONSOLIS

Not for opioid non-tolerant patients. Acute or post-op pain (including headache/migraine, dental pain, or ER).

Warnings/Precautions for ONSOLIS

Respiratory disorders or depression. Head injury. Increased intracranial pressure. Bradycardia. Impaired pulmonary, cardiovascular, renal, or hepatic function. Store and dispose of properly. Elderly. Debilitated. Pregnancy (Cat.C). Labor & delivery, nursing mothers: not recommended.

Interactions for ONSOLIS

Not recommended within 14 days of MAOIs . Potentiates CNS depression with alcohol, other CNS depressants (eg, phenothiazines, skeletal muscle relaxants, antihistamines, hypnotics). Potentiated by CYP3A4 inhibitors (eg, macrolides, azole antifungals, aprepitant, protease inhibitors, nefazodone, verapamil, diltiazem). Antagonized by CYP3A4 inducers (eg, barbiturates, efavirenz, modafinil, nevirapine, anticonvulsants, pioglitazone, troglitazone, rifabutin, rifampin, St John's wort).

Adverse Reactions for ONSOLIS

GI upset, dizziness, dehydration, dyspnea, somnolence; respiratory or circulatory depression, hypotension, shock, drowsiness, anticholinergic effects, others.

Notes for ONSOLIS

Available by restricted distribution program. Call (877) 4ONSOLIS or visit www.OnsolisFocus.com to enroll. Caution patients and caregivers in proper handling and disposal; may be fatal to children.

How is ONSOLIS supplied?

Films—30

FDA批准阿片类止痛药Onsolis用于癌症患者

FDA已批准阿片类止痛药Onsolis用于癌症患者，以缓解重度急性发作型疼痛，这类患者在使用其他镇痛药时也可同时使用Onsolis。该药由Aveva制药公司生产，并由Meda AB公司销售，它将于今年第四季度上市。

Onsolis为强效麻醉性镇痛药芬太尼的一种可溶性聚合物膜制剂，使用时贴敷于面颊内表面。那些已经采用过其他阿片类药物治疗但效果不佳，需要增加药物缓解突发性剧痛的癌症患者可以使用该药，这类患者对阿片类药物具有良好的耐受性。

FDA相关负责人在一份声明中指出，那些对阿片类药耐受不好的患者使用Onsolis后，可导致用药过量、突发性重度呼吸困难甚至死亡。

Onsolis® (fentanyl buccal soluble film)
ONSOLIS utilizes the BioErodible MucoAdhesive (BEMA®) drug delivery technology, which consists of a small, bioerodible polymer film for application to the buccal mucosa (inner lining of the cheek). ONSOLIS is an opioid analgesic indicated only for the management of breakthrough pain in patients with cancer, 18 years of age and older, who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. For additional ONSOLIS information including the full prescribing information and medication guide, go to www.onsolis.com. See below for important safety information.

Commercialization rights to ONSOLIS have been licensed to Meda globally, with the exception of Taiwan and South Korea. Meda is an international specialty pharmaceutical company that concentrates on marketing and market-adapted product development. Meda is represented in 26 countries and with more than 1,500 employees within marketing and sales. Meda's products are sold in approximately 120 countries world-wide.

Meda Pharmaceuticals Inc. is the U.S. subsidiary of Meda. Meda Pharmaceuticals specializes in central nervous system, respiratory, and allergy products. BDSI® considers Meda to be an ideal partner and well suited to commercialize ONSOLIS. Find out more about Meda by visiting www.medapharma.us or www.meda.se.

ONSOLIS has also been licensed in Taiwan (Kunwha Pharmaceutical) and South Korea (TTY Biopharm), allowing for global product commercialization.

IMPORTANT SAFETY INFORMATION

ONSOLIS is an opioid analgesic indicated only for the management of breakthrough pain in patients with cancer, 18 years of age and older, who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain.

ONSOLIS is contraindicated in opioid non-tolerant patients; acute or postoperative pain, including headache/migraine, dental pain, or use in the emergency room; and patients with intolerance or hypersensitivity to fentanyl, ONSOLIS, or its components. Life-threatening respiratory depression could occur in patients not taking chronic opiates.

ONSOLIS contains fentanyl, a Schedule II controlled substance with abuse liability similar to other opioid analgesics.

Clinically significant respiratory and CNS depression can occur, patients should be monitored accordingly. ONSOLIS films contain medicine in an amount that can be fatal to a child. Keep out of the reach of children and dispose of unneeded films properly. Use with other CNS depressants or CYP3A4 inhibitors may increase depressant effects including hypoventilation (which may lead to potentially fatal respiratory depression), hypotension, and profound sedation; dosage adjustments may be warranted. ONSOLIS may impair ability for the performance of potentially dangerous tasks (e.g., driving a car or operating machinery). ONSOLIS should be titrated cautiously in patients with chronic obstructive pulmonary disease or preexisting medical conditions predisposing them to hypoventilation. ONSOLIS should be administered with extreme caution in patients susceptible to intracranial effects of CO2 retention.

Substantial differences exist in the pharmacokinetic profile of ONSOLIS compared to other fentanyl products that result in clinically important differences in the extent of absorption of fentanyl. As a result of these differences, the substitution of ONSOLIS for any other fentanyl product may result in fatal overdose.

The most common adverse reactions (frequency ≥10%) seen in ONSOLIS clinical trials were: nausea, vomiting, dizziness, dehydration, dyspnea, and somnolence.

Safety and efficacy below age 18 years have not been established. ONSOLIS should be administered with caution to patients with renal or hepatic impairment.

ONSOLIS is available only through a restricted distribution program called the ONSOLIS REMS Program and requires prescriber, pharmacy, and patient enrollment.

Full Prescribing Information for ONSOLIS, including boxed warning, is available at www.onsolis.com or Meda Pharmaceuticals Inc. (1-800-526-3840).