Table 1.
Selected buccal/sublingual drug products approved by FDA for systemic drug delivery.
| Drug Name | Active Ingredients | Molecular Weight (g/mol) | Dosage Form | Administration Route | Company | Approval Date |
|---|---|---|---|---|---|---|
| Metandren® | Methyltestosterone | 302.5 | Tablet | Buccal, Sublingual | Novartis, Basel, Switzerland | - |
| Sorbitrate® | Isosorbide dinitrate | 236.1 | Tablet | Sublingual | Astrazeneca, Cambridge, UK | - |
| Isuprel® | Isoproterenol hydrochloride | 247.7 | Tablet | Sublingual, Rectal | Sanofi-Aventis US, Bridgewater (NJ), U.S. | 1948 |
| Hydergine® | Ergoloid mesylates | - | Tablet | Sublingual | Novartis, Basel, Switzerland | 1953 |
| Isordil® | Isosorbide dinitrate | 236.1 | Tablet | Sublingual | Biovail, Ontario, Canada | 1961 |
| Dentipatch® | Lidocaine | 234.3 | Film | Buccal | Noven, Miami (FL), U.S. | 1996 |
| Nitrostat® | Nitroglycerin | 227.1 | Tablet | Sublingual | Upjohn, Hastings (MI), U.S. | 2000 |
| Suboxone® | Buprenorphine hydrochloride; Naloxone hydrochloride | 504.1, 363.8 | Tablet | Sublingual | Indivior, Richmond (VA), U.S. | 2002 |
| Subutex® | Buprenorphine hydrochloride | 504.1 | Tablet | Sublingual | Indivior, Richmond (VA), U.S. | 2002 |
| Striant® | Testosterone | 288.4 | Tablet | Buccal | Auxilium Pharms, Centerbrook (CT), U.S. | 2003 |
| Fentora® | Fentanyl citrate | 528.6 | Tablet | Buccal, Sublingual | Cephalon, Frazer (PA), U.S. | 2006 |
| Edluar® | Zolpidem tartrate | 764.9 | Tablet | Sublingual | Mylan Speciality Lp, Basking Ridge (NJ), U.S. | 2009 |
| Saphris® | Asenapine maleate | 401.8 | Tablet | Sublingual | Allergan, Dublin, Ireland | 2009 |
| Onsolis® | Fentanyl citrate | 528.6 | Film | Buccal | BioDelivery Sciences International, Raleigh (NC), U.S. | 2009 |
| Suboxone® | Buprenorphine hydrochloride; Naloxone hydrochloride | 504.1, 363.8 | Film | Buccal, Sublingual | Indivior, Richmond (VA), U.S. | 2010 |
| Intermezzo® | Zolpidem tartrate | 764.9 | Tablet | Sublingual | Purdue Pharma, Stamford (CT), U.S. | 2011 |
| Abstral® | Fentanyl citrate | 528.6 | Tablet | Sublingual | Sentynl Theraps, Solana Beach (CA), U.S. | 2011 |
| Zubsolv® | Buprenorphine hydrochloride; Naloxone hydrochloride | 504.1, 363.8 | Tablet | Sublingual | Orexo US Inc., Morristown (NJ), U.S. | 2013 |
| Bunavail® | Buprenorphine hydrochloride; Naloxone hydrochloride | 504.1, 363.8 | Film | Buccal | BioDelivery Sciences International, Raleigh (NC), U.S. | 2014 |
| Belbuca® | Buprenorphine hydrochloride | 504.1 | Film | Buccal | BioDelivery Sciences International, Raleigh (NC), U.S. | 2015 |
| Dsuvia® | Sufentanil citrate | 578.7 | Tablet | Sublingual | Acelrx Pharmaceuticals, Hayward (CA), U.S. | 2018 |
| Nocdurna® | Desmopressin acetate | 1129.3 | Tablet | Sublingual | Ferring Pharmaceuticals, Saint-Prex, Switzerland | 2018 |
| Cassipa® | Buprenorphine hydrochloride; Naloxone hydrochloride | 504.1, 363.8 | Film | Sublingual | Teva Pharmaceuticals, Tel Aviv, Isreal | 2018 |
| Kynmobi® | Apomorphine hydrochloride | 303.8 | Film | Sublingual | Sunovion Pharmaceuticals, Marlborough (MA), U.S. | 2020 |
| Igalmi® | Dexmedetomidine | 200.28 | Film | Sublingual | BioXcel Therapeutics, New Haven (CT), U.S. | 2022 |