Published : Jun-2018
No. of Pages : 194
1 Table of Contents 2
1.1 List of Tables 7
1.2 List of Figures 11
2 Introduction 12
2.1 Transmucosal Drug Delivery Overview 12
3 Products under Development 13
3.1 Transmucosal Drug Delivery - Pipeline Products by Stage of Development 13
3.2 Transmucosal Drug Delivery - Pipeline Products by Segment 14
3.3 Transmucosal Drug Delivery - Pipeline Products by Territory 15
3.4 Transmucosal Drug Delivery - Pipeline Products by Regulatory Path 16
3.5 Transmucosal Drug Delivery - Pipeline Products by Estimated Approval Date 17
3.6 Transmucosal Drug Delivery - Ongoing Clinical Trials 18
4 Transmucosal Drug Delivery - Pipeline Products under Development by Companies 19
4.1 Transmucosal Drug Delivery Companies - Pipeline Products by Stage of Development 19
4.2 Transmucosal Drug Delivery - Pipeline Products by Stage of Development 21
5 Transmucosal Drug Delivery Companies and Product Overview 23
5.1 AcelRx Pharmaceuticals Inc Company Overview 23
5.2 Albert Einstein College of Medicine Company Overview 29
5.3 Allergan Plc Company Overview 30
5.4 Amphastar Pharmaceuticals Inc Company Overview 31
5.5 BeFree! Company Overview 32
5.6 Bespak Europe Ltd Company Overview 33
5.7 Biorings LLC Company Overview 35
5.8 BMG Pharma srl Company Overview 36
5.9 Columbia University Company Overview 38
5.10 Combinent BioMedical Systems Inc Company Overview 39
5.11 Conrad Company Overview 40
5.12 Corium International Inc Company Overview 42
5.13 Dare Bioscience Inc Company Overview 44
5.14 Dermtreat ApS Company Overview 49
5.15 Emergent BioSolutions Inc Company Overview 52
5.16 Evestra Inc Company Overview 53
5.17 Evofem Biosciences Inc Company Overview 56
5.18 Ferring Pharmaceuticals A/S Company Overview 57
5.19 Ghent University Company Overview 59
5.20 Karessa Pharma AB Company Overview 60
5.21 Kytogenics Pharmaceuticals Inc Company Overview 62
5.22 Laboratoire HRA Pharma SAS Company Overview 63
5.23 Laboratorios Andromaco Company Overview 64
5.24 McNeil AB Company Overview 65
5.25 Merck & Co Inc Company Overview 66
5.26 Merck Serono SA Company Overview 67
5.27 Merck Sharp & Dohme Ltd Company Overview 69
5.28 Mercy Research and Development Company Overview 70
5.29 Mithra Pharmaceuticals SA Company Overview 71
5.30 Mystic Pharmaceuticals Inc Company Overview 72
5.31 Nanosys Inc Company Overview 74
5.32 NorInvent AB Company Overview 75
5.33 Novus Therapeutics Inc Company Overview 76
5.34 Oak Crest Institute of Science Company Overview 77
5.35 Opiant Pharmaceuticals Inc Company Overview 78
5.36 OptiNose AS Company Overview 82
5.37 RDD Pharma Ltd Company Overview 84
5.38 Rhinomed Ltd Company Overview 87
5.39 Shin Nippon Biomedical Laboratories Ltd Company Overview 88
5.40 Sonoma Pharmaceuticals Inc Company Overview 89
5.41 Texas Tech University Company Overview 90
5.42 The Hong Kong University of Science and Technology Company Overview 91
5.43 Therakind Ltd Company Overview 92
5.44 UCB SA Company Overview 93
5.45 University of North Carolina at Chapel Hill Company Overview 94
5.46 University of South Florida Company Overview 95
5.47 University of Texas at Austin Company Overview 96
5.48 University of the Witwatersrand Company Overview 97
5.49 University of Washington Company Overview 98
5.50 Yale School of Medicine Company Overview 99
6 Transmucosal Drug Delivery- Recent Developments 100
6.1 Jun 06, 2018: Dare Bioscience Expands Leadership Team, Appointing David Friend, Ph.D. to Chief Scientific Officer 100
6.2 Jun 04, 2018: Dare Bioscience Appoints Mary Jarosz To Global Head Of Regulatory Affairs 100
6.3 Jun 04, 2018: RDD Pharma Names Dr. Mark Sirgo As Chairman Of The Board Of Directors 101
6.4 May 29, 2018: Egalet Announces Large Regional Plan to Cover SPRIX Nasal Spray 101
6.5 May 29, 2018: ADAPT Pharma Launches New Online Platform for NARCAN 102
6.6 May 28, 2018: Update on Mithra and Mayne Pharma's Vaginal Contraceptive Ring Opportunity 102
6.7 May 24, 2018: AcelRx announces FDA acceptance of NDA for DSUVIA 103
6.8 May 21, 2018: Summit Medical Group Research Aids in FDA Approval of Drug for Nasal Polyps 104
6.9 May 18, 2018: Avadel to Present Late-Breaker Data and Product Theater Forum at the 2018 American Urological Association Annual Meeting 104
6.10 May 15, 2018: Dare Bioscience Announces Trial Initiation for Ovaprene Non-Hormonal Monthly Contraceptive Candidate 106
6.11 May 14, 2018: Corium Announces Second Quarter Fiscal 2018 Financial Results 106
6.12 May 10, 2018: BioDelivery Sciences Reports Positive First Quarter 2018 Financial Results and Provides Corporate Update 108
6.13 May 09, 2018: Quebec Government makes NARCAN Nasal Spray free to anyone 14 years or older through Free naloxone program 109
6.14 May 09, 2018: AcelRx resubmits New Drug Application for DSUVIA 110
6.15 May 09, 2018: AcelRx Pharmaceuticals Reports First Quarter 2018 Financial Results 111
6.16 May 08, 2018: Dare Bioscience Expands Leadership Team, Appointing John Fair to Chief Business Officer 111
6.17 May 08, 2018: Sonoma Pharmaceuticals Names Marc Umscheid Chief Operating Officer 112
6.18 May 07, 2018: Optinose Provides Update on XHANCE 112
6.19 May 07, 2018: BioDelivery Sciences Names Herm Cukier As Chief Executive Officer 112
6.20 May 01, 2018: Avadel Launches NOCTIVA, the First and Only FDA-Approved Treatment for Nocturia Due to Nocturnal Polyuria 113
6.21 Apr 30, 2018: AcelRx Pharmaceuticals Reports Publication Analyzing Errors Associated with Existing IV Patient-Controlled Analgesia Systems 114
6.22 Apr 30, 2018: A Retrospective Analysis & Literature Review Published in Pain Management on the Pharmacokinetic Properties of Naloxone Approved for Community Use Highlights Bioequivalence of Dose & Usability 114
6.23 Apr 30, 2018: Dare Bioscience announces funding award to further the development of Ovaprene from the National Institutes of Health Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) 115
6.24 Apr 26, 2018: Adapt Pharma donates 20,000 doses of NARCAN (naloxone HCl) Nasal Spray to the National Council for Behavioral Health and its Residential Treatment Member Organizations 116
6.25 Apr 26, 2018: Consort Medical: Director Declaration 117
6.26 Apr 25, 2018: Dermtreat Appoints Nishan de Silva, M.D., as CEO; Establishes North American Headquarters in San Diego 117
6.27 Apr 25, 2018: A Retrospective Literature Review Published in Pain Management on Prescribing Naloxone for Opioid Overdose Intervention Highlights Opportunities to Expand Community Access to Help Reduce Fatalities 118
6.28 Apr 16, 2018: AcelRx Announces Completion of the Human Factors Study for DSUVIA and Confirms Plans to Resubmit NDA in Q2 2018 119
6.29 Apr 11, 2018: Jessica Grossman Joins Dare Bioscience Board of Directors 119
6.30 Apr 09, 2018: Adapt Pharma Welcomes Canadian & Ontario Governments Programs Providing NARCAN (naloxone HCl) Nasal Spray Free of Charge to NIHB Clients and All Ontarians through Pharmacies 119
6.31 Apr 05, 2018: ADAPT Pharma Welcomes Surgeon General Naloxone Advisory 121
6.32 Apr 05, 2018: Naloxone Nasal Spray now available to First Nations and Inuit through Non-Insured Health Benefits program 122
6.33 Apr 05, 2018: CVS Health Expands Efforts to Educate Patients about Naloxone 122
6.34 Apr 04, 2018: Cardinal Health Begins Donation of Over 80,000 Doses of Life-Saving Narcan for Distribution to Law Enforcement and First Responders in Appalachia 123
6.35 Apr 02, 2018: Intersect ENT Announces Launch of SINUVA Sinus Implant, a New In-Office Treatment Option for Recurrent Nasal Polyps 124
6.36 Mar 27, 2018: AcelRx Pharmaceuticals Names John Saia As General Counsel 125
6.37 Mar 20, 2018: Mithra And Mayne Pharma Vaginal Contraceptive Ring Accepted For Filing By FDA 125
6.38 Mar 19, 2018: ADAPT Pharma Expands Program Offering Free NARCAN (naloxone HCl) Nasal Spray to Eligible Schools and Universities 126
6.39 Mar 16, 2018: Intention to grant for the XtriG-patent in Europe 127
6.40 Mar 16, 2018: BioDelivery Sciences Announces Fourth Quarter and Full-Year 2017 Financial Results 127
6.41 Mar 13, 2018: Injectable Medication Shortage is Affecting Terminally Ill Patients 129
6.42 Mar 08, 2018: Notice of Allowance for XtriG patent in the USA 130
6.43 Mar 08, 2018: AcelRx Pharmaceuticals Reports Fourth Quarter 2017 Financial Results 130
6.44 Mar 07, 2018: Ontario Government takes significant action to address opioid crisis; NARCAN Nasal Spray to be made available to all Ontarians free of charge through pharmacies 131
6.45 Mar 06, 2018: High uptake and use of vaginal ring for HIV prevention observed in open-label study 132
6.46 Feb 27, 2018: Optinose to Highlight Data at the 2018 AAAAI/WAO Joint Congress 134
6.47 Feb 22, 2018: Teleflex Highlights LMA Gastro Airway Study, Which Shows Efficacy for Use in Upper Gastrointestinal Endoscopy 135
6.48 Feb 08, 2018: AptarGroup and Adapt Pharma Donate NARCAN Nasal Spray to Opioid Crisis Coalitions in Illinois 135
6.49 Feb 08, 2018: Opiant Pharmaceuticals to Record Approximately $11.7 Million in Royalty and Milestone Payments Related to 2017 Sales of NARCAN Nasal Spray for Opioid Overdose 137
6.50 Feb 08, 2018: Opiant Pharmaceuticals to Record Approximately $11.7 Million in Royalty and Milestone Payments Related to 2017 Sales of NARCAN Nasal Spray for Opioid Overdose 137
6.51 Feb 08, 2018: Corium Reports First Quarter Fiscal 2018 Financial Results and Corporate Highlights 137
6.52 Feb 07, 2018: Sonoma Pharmaceuticals Reports Record Total Revenue of $4.8 million for Third Quarter FY 2018 with Year over Year Product Revenue Growth of 46% 139
6.53 Feb 06, 2018: BioDelivery Sciences Announces BELBUCA Patent Litigation Settlement Agreement with Teva 140
6.54 Jan 22, 2018: Intersect ENT Announces Publication of Randomized Pivotal Study of the SINUVA Sinus Implant, a New In-Office Treatment Option for Recurrent Nasal Polyps 140
6.55 Jan 11, 2018: Dermtreat Submits IND And CTA For Phase 2b Study 142
6.56 Jan 04, 2018: RDD Pharma Completes Enrollment in European Phase 3 Clinical Trial for Chronic Anal Fissure 143
7 Appendix 190
7.1 Methodology 190
7.2 About GlobalData 193
7.3 Contact Us 193
7.4 Disclaimer 193
1.1 List of Tables
Table 1: Transmucosal Drug Delivery - Pipeline Products by Stage of Development 14
Table 2: Transmucosal Drug Delivery - Pipeline Products by Segment 15
Table 3: Transmucosal Drug Delivery - Pipeline Products by Territory 16
Table 4: Transmucosal Drug Delivery - Pipeline Products by Regulatory Path 17
Table 5: Transmucosal Drug Delivery - Pipeline Products by Estimated Approval Date 18
Table 6: Transmucosal Drug Delivery - Ongoing Clinical Trials 19
Table 7: Transmucosal Drug Delivery Companies - Pipeline Products by Stage of Development 20
Table 8: Transmucosal Drug Delivery - Pipeline Products by Stage of Development 22
Table 9: AcelRx Pharmaceuticals Inc Pipeline Products & Ongoing Clinical Trials Overview 24
Table 10: ARX-02 Sufentanil NanoTab BTP Management System - Product Status 24
Table 11: ARX-02 Sufentanil NanoTab BTP Management System - Product Description 25
Table 12: ARX-03 Sufentanil/Trazolam NanoTab - Product Status 25
Table 13: ARX-03 Sufentanil/Trazolam NanoTab - Product Description 25
Table 14: DSUVIA Single-Dose Applicator - Product Status 26
Table 15: DSUVIA Single-Dose Applicator - Product Description 26
Table 16: ZALVISO - Product Status 26
Table 17: ZALVISO - Product Description 27
Table 18: AcelRx Pharmaceuticals Inc - Ongoing Clinical Trials Overview 28
Table 19: ZALVISO - Treatment of Acute Post-operative Pain in Patients Undergoing Laparoscopic Colon Resections 29
Table 20: ZALVISO - Usability and Satisfaction Evaluation of Sufentanil Sublingual Patient-Controlled Analgesia After Elective Surgery With Moderate-to-Severe Postoperative Pain 29
Table 21: Albert Einstein College of Medicine Pipeline Products & Ongoing Clinical Trials Overview 30
Table 22: Drug-Impregnated Intravaginal Ring - Product Status 30
Table 23: Drug-Impregnated Intravaginal Ring - Product Description 30
Table 24: Allergan Plc Pipeline Products & Ongoing Clinical Trials Overview 31
Table 25: Vaginal Ring Contraceptive - Product Status 31
Table 26: Vaginal Ring Contraceptive - Product Description 31
Table 27: Amphastar Pharmaceuticals Inc Pipeline Products & Ongoing Clinical Trials Overview 32
Table 28: Intranasal Naloxone Spray - Product Status 32
Table 29: Intranasal Naloxone Spray - Product Description 32
Table 30: BeFree! Pipeline Products & Ongoing Clinical Trials Overview 33
Table 31: Vaginal Drug Delivery System - Product Status 33
Table 32: Vaginal Drug Delivery System - Product Description 33
Table 33: Bespak Europe Ltd Pipeline Products & Ongoing Clinical Trials Overview 34
Table 34: NAS010 - Product Status 34
Table 35: NAS010 - Product Description 34
Table 36: NAS020 - Unidose Nasal Drug Delivery Device - Product Status 35
Table 37: NAS020 - Unidose Nasal Drug Delivery Device - Product Description 35
Table 38: NAS030 Nasal Device - Product Status 35
Table 39: NAS030 Nasal Device - Product Description 35
Table 40: Biorings LLC Pipeline Products & Ongoing Clinical Trials Overview 36
Table 41: Vaginal Ring - Product Status 36
Table 42: Vaginal Ring - Product Description 36
Table 43: BMG Pharma srl Pipeline Products & Ongoing Clinical Trials Overview 37
Table 44: Isysin Hyper - Product Status 37
Table 45: Isysin Hyper - Product Description 37
Table 46: Isysin Iso - Product Status 37
Table 47: Isysin Iso - Product Description 38
Table 48: Columbia University Pipeline Products & Ongoing Clinical Trials Overview 39
Table 49: Focused Ultrasound - Intranasal Drug Delivery - Product Status 39
Table 50: Focused Ultrasound - Intranasal Drug Delivery - Product Description 39
Table 51: Combinent BioMedical Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 40
Table 52: Multi-Segmented Vaginal Ring - Product Status 40
Table 53: Multi-Segmented Vaginal Ring - Product Description 40
Table 54: Conrad Pipeline Products & Ongoing Clinical Trials Overview 41
Table 55: Triple Protection Vaginal Ring - Product Status 41
Table 56: Triple Protection Vaginal Ring - Product Description 41
Table 57: Vaginal Ring - HIV Protection - Product Status 42
Table 58: Vaginal Ring - HIV Protection - Product Description 42
Table 59: Corium International Inc Pipeline Products & Ongoing Clinical Trials Overview 43
Table 60: Rapidly Dissolving Film - Product Status 43
Table 61: Rapidly Dissolving Film - Product Description 43
Table 62: Solid State Film - Product Status 44
Table 63: Solid State Film - Product Description 44
Table 64: Dare Bioscience Inc Pipeline Products & Ongoing Clinical Trials Overview 45
Table 65: Intravaginal Ring - Product Status 45
Table 66: Intravaginal Ring - Product Description 46
Table 67: Ovaprene - Product Status 46
Table 68: Ovaprene - Product Description 46
Table 69: Dare Bioscience Inc - Ongoing Clinical Trials Overview 47
Table 70: Ovaprene - Post-coital Test (PCT) Clinical Study to Evaluate Safety and Efficacy of Ovaprene Non-hormonal Monthly Contraceptive Candidate 48
Table 71: Intravaginal Ring - A Phase I Clinical Study of JNP-0201 49
Table 72: Intravaginal Ring - A Phase I Clinical Study of JNP-0301 49
Table 73: Intravaginal Ring - Phase IIa Study of JNP-0101 49
Table 74: Intravaginal Ring - Phase III Study of JNP-0101 49
Table 75: Dermtreat ApS Pipeline Products & Ongoing Clinical Trials Overview 50
Table 76: Rivelin Clobetasol Patch - Product Status 50
Table 77: Rivelin Clobetasol Patch - Product Description 50
Table 78: Dermtreat ApS - Ongoing Clinical Trials Overview 51
Table 79: Rivelin Clobetasol Patch - Phase IIb Clinical Study of Rivelin Clobetasol Patch in Treatment of Oral Lichen Planus (OLP) 52
Table 80: Emergent BioSolutions Inc Pipeline Products & Ongoing Clinical Trials Overview 53
Table 81: Intranasal SIAN Device - Product Status 53
Table 82: Intranasal SIAN Device - Product Description 53
Table 83: Evestra Inc Pipeline Products & Ongoing Clinical Trials Overview 54
Table 84: EVE112 - Vaginal Ring - Product Status 54
Table 85: EVE112 - Vaginal Ring - Product Description 54
Table 86: EVE116 - Product Status 55
Table 87: EVE116 - Product Description 55
Table 88: Progestin Vaginal Ring - Product Status 55
Table 89: Progestin Vaginal Ring - Product Description 56
Table 90: Vaginal Ring For Preterm Labor - Product Status 56
Table 91: Vaginal Ring For Preterm Labor - Product Description 56
Table 92: Evofem Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 57
Table 93: Nestorone/Ethinyl estradiol (NES/EE) Contraceptive Vaginal Ring (CVR) - Product Status 57
Table 94: Nestorone/Ethinyl estradiol (NES/EE) Contraceptive Vaginal Ring (CVR) - Product Description 57
Table 95: Ferring Pharmaceuticals A/S Pipeline Products & Ongoing Clinical Trials Overview 58
Table 96: C-Vad Vaginal Insert - Product Status 58
Table 97: C-Vad Vaginal Insert - Product Description 58
Table 98: Premis Vaginal Insert - Product Status 59
Table 99: Premis Vaginal Insert - Product Description 59
Table 100: Ghent University Pipeline Products & Ongoing Clinical Trials Overview 60
Table 101: Controlled-Release System - Intra-Vaginal Delivery - Product Status 60
Table 102: Controlled-Release System - Intra-Vaginal Delivery - Product Description 60
Table 103: Karessa Pharma AB Pipeline Products & Ongoing Clinical Trials Overview 61
Table 104: K-01 - Product Status 61
Table 105: K-01 - Product Description 61
Table 106: K-02 - Product Status 62
1.2 List of Figures
Figure 1: Transmucosal Drug Delivery - Pipeline Products by Stage of Development 14
Figure 2: Transmucosal Drug Delivery - Pipeline Products by Segment 15
Figure 3: Transmucosal Drug Delivery - Pipeline Products by Territory 16
Figure 4: Transmucosal Drug Delivery - Pipeline Products by Regulatory Path 17
Figure 5: Transmucosal Drug Delivery - Pipeline Products by Estimated Approval Date 18
Figure 6: Transmucosal Drug Delivery - Ongoing Clinical Trials 19
