2017 Year-End Update on FDA Approved Thin Film Products
The Criticality of Adhesive Selection
February 13, 2017
ARx Showcases Mucosal Thin Film Drug Delivery at Industry Events
July 23, 2018

2017 Year-End Update on FDA Approved Thin Film Products

The US Food and Drug Administration (FDA) approved its last novel drug of 2017, Giaprezaon to increase blood pressure in adults with septic or other distributive shocks on December 21st of last year. Giaprezaon brought the total Novel Drug Approvals for the year to 46. According to a Pharma Compass article published in Jan of 2018 (https://www.pharmacompass.com/radio-compass-blog/2017-closes-with-record-approvals-of-generics-novel-drugs-2018-begins-with-reprieves-for-teva), 46 approvals is a new record for the FDA. In addition, the FDA also had a record number of generic drug approvals, the most ever novel devices, and the first ever gene therapies. Unfortunately, there were no new oral thin film or mucosal thin film products approved by the FDA in 2017. The last two products approved by the FDA under the 505(b)(2) path were Belbuca® for chronic pain and Bunavail® for opioid addiction. A company by the name of BioDelivery Sciences International (BDSI) is the NDA holder of these two products. With 3 of the 6 thin film products approved by the FDA, BDSI is certainly a market leader in this dosage form. From the chart below, one can see that thin film products center around a few large markets including pain, opioid addiction, and vomiting & nausea. ARx is pleased to share that we have partnered on 50% of the programs listed below to get the products approved by the FDA and available to patients in need. We also hope to add additional products to this list in 2018. Contact us to learn more about the benefits of thin film drug delivery.

Approval Date NDA Number Product Name & Marketer Active Strengths Indication Absorption
1 July 16, 2009
NDA 022266
Onsolis® Buccal Soluble FilmBioDelivery Sciences International Fentanyl Citrate 200 mcg400 mcg600 mcg800 mcg1200 mcg Breakthrough pain in cancer patients who are already receiving and who are tolerant to opioid therapy Buccal
2 Nov 25, 2009
NDA 022470
Nexcede® Oral FilmNovartis Consumer Health Ketoprofen 12.5mg Temporary relief of minor aches and pains Oral/GI
Swallowed
3 July 2, 2010
NDA 022524
Zuplenz® Oral Soluble FilmMidatech Pharma US Ondansetron base 4mg8mg Prevention of nausea and vomiting associated with various episodes Oral/GI
Swallowed
4 Aug 30, 2010
NDA 022410
Suboxone® Sublingual filmIndivior Inc. Buprenorphine HClNaloxone HCl 2mg bup/0.5mg nal4mg/1mg8mg/2mg12mg/3mg Opioid dependence Sublingual Buccal
5 June 6, 2014
NDA 205637
Bunavail® Buccal FilmBioDelivery Sciences International Buprenorphine HClNaloxone HCl 2.1mg bup/0.3mg nal4.2mg/0.7mg6.3mg/1mg Opioid dependence Buccal
6 Oct 23, 2015
NDA 207932
Belbuca® Buccal FilmBioDelivery Sciences International Buprenorphine HCl 75 mcg150 mcg300 mcg450 mcg600 mcg750 mcg900 mcg Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate Buccal