Medicine:List of drugs granted breakthrough therapy designation

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Below is a list of drugs granted breakthrough therapy designation (BTD) by the Food and Drug Administration (FDA).

Drugs may be listed more than once as BTD can be awarded for multiple indications.

2020

Drug Manufacturer Indication
Avapritinib Blueprint Medicines Corp metastatic gastrointestinal stromal tumor
Tepezza Horizon Therapeutics thyroid eye disease
Nintedanib Boehringer Ingelheim chronic fibrosing interstitial lung diseases
Ipilimumab Bristol-Myers Squibb hepatocellular carcinoma
Nivolumab Bristol-Myers Squibb hepatocellular carcinoma
Selumetinib AstraZeneca neurofibromatosis type 1
Mitomycin Urogen Pharma upper tract urothelial cancer
Tucatinib Seattle Genetics advanced unresectable or metastatic HER2-positive breast cancer
Pemigatinib Incyte Corp metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion
Trodelvy Immunomedics metastatic triple-negative breast cancer
Capmatinib Novartis metastatic non-small cell lung cancer
Selpercatinib Loxo Oncology metastatic RET fusion-positive non-small cell lung cancer
Ripretinib Deciphera Pharmaceuticals advanced gastrointestinal stromal tumor
Artesunate Amivas LLC severe malaria
Bevacizumab Genentech metastatic hepatocellular carcinoma
Atezolizumab Genentech metastatic hepatocellular carcinoma
Inebilizumab Viela Bio neuromyelitis optica spectrum disorder
Fostemsavir Viiv Healthcare Co multidrug-resistant HIV-1
Monjuvi MorphoSys relapsed or refractory diffuse large B-cell lymphoma
Esketamine Janssen major depressive disorder with acute suicidal ideation or behavior[1]
Blenrep GlaxoSmithKline refractory multiple myeloma
Enspryng Genentech neuromyelitis optica spectrum disorder
Pralsetinib Blueprint Medicines Corp RET fusion-positive non-small cell lung cancer

D-PLEX 100 || PolyPid Ltd|| Prevention of Surgical Site Infections (SSI)

2019

Drug Manufacturer Indication
Psilocybin Usona Institute major depressive disorder[2]
B38M (JNJ‐4528) Legend Biotech/Janssen multiple myeloma
Rilonacept Kiniska Pharmaceuticals recurrent pericarditis
Inmazeb Regeneron Ebola Virus
Olorofim F2G invasive mold infections
Nintedanib Boehringer Ingelheim interstitial lung disease
Niraparib Janssen castration-resistant prostate cancer
Cobimetinib Memorial Sloan Kettering histiocytic neoplasms
Tepotinib Merck metastatic non-small cell lung cancer
Ansuvimab Ridgeback Biotherapeutics Ebola Virus
Capmatinib Novartis metastatic non-small cell lung cancer
Nirogacestat SpringWorks Therapeutics refractory desmoid tumors
Bempegaldesleukin Nektar Therapeutics melanoma
Peginterferon Lambda Eiger BioPharmaceuticals hepatitis delta virus infection
Acalabrutinib AstraZeneca chronic lymphocytic leukemia
Trilaciclib G1 Therapeutics small-cell lung cancer
Nedosiran Dicerna Pharmaceuticals primary hyperoxaluria
Pembrolizumab Merck hepatocellular carcinoma
Avexitide Eiger BioPharmaceuticals post-bariatric hypoglycemia
Copanlisib Bayer marginal zone lymphoma
LN-145 Iovance Biotherapeutics cervical cancer
Trastuzumab deruxtecan Daiichi Sankyo HER2-positive breast cancer
SER-109 Seres Therapeutics Clostridioides difficile infection
I.V. Artesunate La Jolla Pharmaceutical malaria
Elafibranor Genfit primary biliary cholangitis
Inebilizumab Viela Bio neuromyelitis optica spectrum disorder
Bentracimab PhaseBio Pharmaceuticals reversal agent for ticagrelor
Selumetinib AstraZeneca/Merck pediatric neurofibromatosis type 1
AXS-05 Axsome Therapeutics major depressive disorder
ivosidenib Agios Pharmaceuticals acute myeloid leukemia
Venetoclax Abbvie chronic lymphocytic leukemia
AT-GAA Amicus Therapeutics Pompe disease
Pralsentinib Blueprint Medicines Non-small cell lung cancer
Seladelpar CymaBay Therapeutics primary biliary cholangitis
CP101 Finch Therapeutics Clostridioides difficile infection
Nirsevimab AstraZeneca respiratory syncytial virus
Kadcyla Genentech HER2-positive breast cancer
Umbralisib TG Therapeutics marginal-zone lymphoma
V114 Merck pneumococcal disease
Zanubrutinib BeiGene USA mantle cell lymphoma
Crizanlizumab Novartis sickle cell disease
Encorafenib Array BioPharma metastatic colorectal cancer

[3]

2018

Drug Manufacturer Indication
Tezacaftor/ivacaftor[1] Vertex Pharmaceuticals cystic fibrosis
Durvalumab[1] AstraZeneca UK unresectable Stage III non-small cell lung cancer (NSCLC)
Ibalizumab-uiyk[1] Theratechnologies human immunodeficiency virus type 1 (HIV-1) infection
Brentuximab vedotin[1] Seattle Genetics Hodgkin lymphoma
Ipilimumab[1] Bristol-Myers Squibb renal cell carcinoma
Nivolumab[1] Bristol-Myers Squibb renal cell carcinoma
Burosumab-twza[1] Kyowa Hakko Kirin X-linked hypophosphatemia
Osimertinib[1] AstraZeneca metastatic non-small cell lung cancer
Dabrafenib[1] Novartis Pharmaceuticals melanoma with BRAF V600E or V600K mutations
Trametinib[1] Novartis Pharmaceuticals melanoma with BRAF V600E or V600K mutations
Dabrafenib[1] Novartis Pharmaceuticals anaplastic thyroid cancer (ATC) with BRAF V600E mutation
Trametinib[1] Novartis Pharmaceuticals anaplastic thyroid cancer (ATC) with BRAF V600E mutation
Fingolimod[1] Novartis Pharmaceuticals multiple sclerosis
Rituximab[1] Genentech pemphigus vulgaris
Venetoclax[1] AbbVie chronic lymphocytic leukemia
Pembrolizumab[1] Merck Sharp & Dohme mediastinal large B-cell lymphoma
Ipilimumab[1] Bristol-Myers Squibb metastatic colorectal cancer
Nivolumab[1] Bristol-Myers Squibb metastatic colorectal cancer
Ribociclib[1] Novartis Pharmaceuticals breast cancer
Tafenoquine[1] GlaxoSmithKline Plasmodium vivax malaria
Iobenguane i 131[1] Progenics Pharmaceuticals pheochromocytoma or paraganglioma
Lumacaftor/ivacaftor[1] Vertex Pharmaceuticals cystic fibrosis
Mogamulizumab-kpkc[1] Kyowa Hakko Kirin mycosis fungoides (MF) or Sézary syndrome (SS)
Patisiran[1] Alnylam Pharmaceuticals hereditary transthyretin-mediated amyloidosis
Cenegermin-bkbj[1] Dompe Farmaceutici neurotrophic keratitis
Lanadelumab-flyo[1] Takeda Pharmaceuticals hereditary angioedema
Cemiplimab-rwlc[1] Regeneron Pharmaceuticals cutaneous squamous cell carcinoma
Amikacin liposome inhalation suspension[1] Insmed mycobacterial lung disease
Emicizumab-kxwh[1] Genentech hemophilia
Lorlatinib[1] Pfizer anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer
Brentuximab vedotin[1] Seattle Genetics anaplastic large-cell lymphoma
Eltrombopag[1] Novartis Pharmaceuticals severe aplastic anemia
Emapalumab-lzsg[1] Swedish Orphan Biovitrum hemophagocytic lymphohistiocytosis
Venetoclax[1] AbbVie acute myeloid leukemia
Larotrectinib[1] Bayer Healthcare solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion
Larotrectinib[1] Bayer Healthcare solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion
Amifampridine[1] Catalyst Pharmaceuticals Lambert-Eaton myasthenic syndrome
Pembrolizumab[1] Merck Sharp & Dohme Merkel cell carcinoma
Tagraxofusp-erzs[1] Stemline Therapeutics blastic plasmacytoid dendritic cell neoplasm
Psilocybin COMPASS Pathways treatment resistant depression[4][5]
Satralizumab Genentech neuromyelitis optica spectrum disorder[citation needed]
Olipudase alfa Sanofi/Genzyme rare inherited disorders[citation needed]
Lonafarib Eiger BioPharmaceuticals Hutchinson-Gilford progeria syndrome[citation needed]
Eltrombopag Novartis thrombocytopenia[citation needed]
Galcanezumab Eli Lilly episodic cluster headache[citation needed]
NRX-101 (Cyclurad) NRx Pharmaceuticals bipolar depression with suicidal ideation[6]
Mitomycin C UroGen Pharma urothelial cancer[citation needed]
Myrcludex MYR Pharma hepatitis delta[citation needed]
Belumosudil Kadmon Holdings graft-versus-host disease[citation needed]
Selpercatinib Loxo Oncology
Selpercatinib Loxo Oncology Non-small cell lung cancer[citation needed]
Rucaparib Clovis Oncology castration-resistant prostate cancer[citation needed]
PF-06482077 Pfizer
Vocacapsaicin Concentric Analgesics
Tezepelumab AstraZeneca/Amgen
Ritlecitinib Pfizer alopecia areata[citation needed]
Danyelza Y-mAbs Therapeutics
Omalizumab Genentech severe allergic reactions[citation needed]
Encorafenib Array BioPharma/Eli Lilly colorectal cancer[citation needed]
Quizartinib Daiichi Sankyo acute myeloid leukemia[citation needed]
Pembrolizumab Merck endometrial carcinoma[citation needed]
Lenvatinib Eisai endometrial carcinoma[citation needed]
Bevacizumab Genentech hepatocellular carcinoma[citation needed]
Atezolizumab Genentech hepatocellular carcinoma[citation needed]
AMT-601 uniQure hemophilia B[citation needed]
HTX-011 Heron Therapeutics Postoperative Pain[citation needed]
Crizotinib Pfizer anaplastic large cell lymphoma[citation needed]
Crizotinib Pfizer small-cell lung cancer[citation needed]
Tafamidis meglumine Foldrx Pharmaceuticals
Lenti-D Bluebird bio cerebral adrenoleukodystrophy[citation needed]
Tafamidis Pfizer transthyretin cardiomyopathy[citation needed]
Pitolisant Harmony Biosciences
Trikafta Vertex Pharmaceuticals cystic fibrosis[citation needed]
Narsoplimab Omeros Corporation thrombotic microangiopathy[citation needed]
Trumenba Pfizer meningococcal disease[citation needed]
Esketamine Johnson & Johnson depression[1]
Sodium thiosulfate Fennec Pharmaceuticals
Enfortumab vedotin Astellas Pharma metastatic urothelial carcinoma[citation needed]
Nesolicaftor Proteostasis Therapeutics cystic fibrosis[citation needed]
Erdafitinib Janssen urothelial carcinoma[citation needed]
Lumasiran Alnylam Pharmaceuticals primary hyperoxaluria[citation needed]
Sutimlimab Bioverativ cold agglutinin disease[citation needed]
Avasopasem manganese Galera Therapeutics oral mucositis[citation needed]
SPK-8011 Spark Therapeutics
Abrocitinib Pfizer atopic dermatitis[citation needed]
Zuranolone Sage Therapeutics major depressive disorder[citation needed]
Fenfluramine Zogenix seizures associated with Dravet syndrome[citation needed]
Balovaptan Hoffman-La Roche autism spectrum disorder[citation needed]
Kisquali Femara Co-Pack Novartis HR-positive, HER2- negative breast cancer[citation needed]
Upadacitinib AbbVie atopic dermatitis[citation needed]
Lenvatinib + Pembrolizumab Merck/Eisai metastatic renal cell carcinoma[citation needed]
Voxelotor Global Blood Therapeutics sickle cell disease[citation needed]
Maribavir Shire Cytomegalovirus infection[citation needed]

[7]

2017

[8]

Drug Manufacturer Indication
Nivolumab[1] Bristol-Myers Squibb urothelial carcinoma
Ribociclib[1] Novartis Pharmaceuticals HR-positive, HER2-negative breast cancer
Pembrolizumab[1] Merck Sharp & Dohme Hodgkin Lymphoma
Avelumab[1] EMD Serono metastatic Merkel cell carcinoma
Niraparib[1] GlaxoSmithKline recurrent ovarian cancer responsive to platinum-based chemotherapy
Ocrelizumab[1] Genentech multiple sclerosis
Dupilumab[1] Regeneron Pharmaceuticals atopic dermatitis
Palbociclib[1] Pfizer HR-positive, HER2-negative breast cancer
Valbenazine[1] Neurocrine Biosciences tardive dyskinesia
Ranibizumab[1] Genentech diabetic retinopathy
Cerliponase alfa[1] BioMarin Pharmaceutical tripeptidyl peptidase 1 (TPP1) deficiency
Midostaurin[1] Novartis Pharmaceuticals FLT3-positive acute myeloid leukemia
Brigatinib[1] Takeda Pharmaceuticals ALK-positive non-small cell lung cancer
Durvalumab[1] AstraZeneca UK metastatic urothelial carcinoma
Letrozole with Ribociclib[1] Novartis Pharmaceuticals breast cancer
Pembrolizumab[1] Merck Sharp & Dohme urothelial carcinoma
Tocilizumab[1] Genentech giant cell arteritis
Pembrolizumab[1] Merck Sharp & Dohme microsatellite instability-high tumors
Ceritinib[1] Novartis Pharmaceuticals anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC)
Dabrafenib[1] Novartis Pharmaceuticals metastatic non-small cell lung cancer with BRAF V600E mutation
Trametinib[1] Novartis Pharmaceuticals metastatic non-small cell lung cancer with BRAF V600E mutation
Ibrutinib[1] Pharmacyclics chronic graft versus host disease (cGVHD)
Glecaprevir/pibrentasvir[1] AbbVie hepatitis C
Cytarabine/daunorubicin[1] Celator Pharmaceuticals acute myeloid leukemia
Inotuzumab ozogamicin[1] Wyeth Pharmaceuticals B-cell precursor acute lymphoblastic leukemia
Deutetrabenazine[1] Teva Pharmaceuticals tardive dyskinesia
Abemaciclib[1] Eli Lilly breast cancer
Acalabrutinib[1] AstraZeneca UK mantle cell lymphoma
Vemurafenib[1] Hoffmann-La Roche Erdheim-Chester disease with BRAF V600 mutation
Alectinib[1] Hoffmann-La Roche anaplastic lymphoma kinase (ALK)-positive, metastatic non-small cell lung cancer (NSCLC)
Letermovir[1] Merck Sharp & Dohme cytomegalovirus (CMV) infection
Letermovir[1] Merck Sharp & Dohme cytomegalovirus (CMV) infection
Brentuximab vedotin[1] Seattle Genetics anaplastic large-cell lymphoma
Emicizumab-kxwh[1] Genentech hemophilia
Nivolumab[1] Bristol-Myers Squibb melanoma
Ribaxamase Synthetic Biologics antibiotic resistance / Clostridioides difficile infection
Midomafetamine (Ecstasy) Multidisciplinary Association for Psychedelic Studies posttraumatic stress disorder[9][10]

2016

Drug Manufacturer Indication
Elbasvir/grazoprevir[1] Merck Sharp & Dohme Hepatitis C
Palbociclib[1] Pfizer HR-positive, HER2-negative breast cancer
Crizotinib[1] PF Prism ROS-1-positive NSCLC
Venetoclax[1] AbbVie CLL with 17p deletion
Cabozantinib[1] Exelixis renal cell carcinoma
Pimavanserin[1] Acadia Pharmaceuticals Parkinson's disease-related psychosis
Ibrutinib[1] Pharmacyclics small lymphocytic lymphoma (SLL) with 17p deletion
Lenvatinib[1] Eisai renal cell carcinoma
Nivolumab[1] Bristol-Myers Squibb Hodgkin lymphoma
Atezolizumab[1] Genentech urothelial carcinoma
Sofosbuvir/velpatasvir[1] Gilead Sciences chronic hepatitis C virus (HCV) genotypes 1, 2, 3, 4, 5 or 6 infection
Canakinumab[1] Novartis Familial mediterranean fever
Canakinumab[1] Novartis Hyper-IgD syndrome
Canakinumab[1] Novartis TNF receptor associated periodic syndrome
Lumacaftor/ivacaftor[1] Vertex Pharmaceuticals cystic fibrosis with CFTR F508del
Atezolizumab[1] Genentech metastatic NSCLC
Olaratumab[1] Eli Lilly soft-tissue sarcoma
Pembrolizumab Merck Sharp & Dohme metastatic NSCLC
Nivolumab[1] Bristol-Myers Squibb head and neck cancer
Daratumumab[1] Janssen multiple myeloma
Daratumumab[1] Janssen multiple myeloma
Oliceridine Trevena Analgesia and pain management
Rucaparib[1] Clovis Oncology BRCA-mutated ovarian cancer
Silver diamine fluoride Elevate Oral Care early childhood caries

2015

Drug Manufacturer Indication
Ibrutinib[1] Pharmacyclics Waldenstrom’s macroglobulinemia
Palbociclib[1] Pfizer ER-positive, HER2-negative breast cancer
Ranibizumab[1] Genentech diabetic retinopathy
Ivacaftor[1] Vertex Pharmaceuticals cystic fibrosis with a variety of CFTR mutations
Aflibercept[1] Regeneron Pharmaceuticals diabetic retinopathy
Sirolimus[1] PF Prism lymphangioleiomyomatosis
Sirolimus[1] PF Prism lymphangioleiomyomatosis
Lumacaftor/ivacaftor[1] Vertex Pharmaceuticals cystic fibrosis with CFTR F508del mutation
Ombitasvir/paritaprevir/ritonavir[1] AbbVie Hepatitis C
Uridine triacetate[1] Wellstat Therapeutics hereditary orotic aciduria
Pembrolizumab[1] Merck Sharp & Dohme PDL-1 positive NSCLC
Nivolumab[1] Bristol-Myers Squibb metastatic NSCLC
Idarucizumab[1] Boehringer Ingelheim reversal of dabigatran
Asfotase alfa[1] Alexion Pharmaceuticals perinatal/infantile/childhood hypophosphatasia
Osimertinib[1] AstraZeneca EGFR-positive NSCLC
Daratumumab[1] Janssen Biotech multiple myeloma
Nivolumab[1] Bristol-Myers Squibb advanced renal cell carcinoma
Elotuzumab[1] Bristol-Myers Squibb multiple myeloma
Sebelipase alfa[1] Alexion Pharmaceuticals lysosomal acid lipase deficiency
Alectinib[1] Hoffmann-La Roche ALK-mutated NSCLC
Pembrolizumab[1] Merck Sharp & Dohme metastatic melanoma
Ibalizumab[11] TaiMed Biologics HIV-1 infection

2014

Drug Manufacturer Indication
Ivacaftor[1] Vertex Pharmaceuticals cystic fibrosis with CFTR mutation
Ofatumumab[1] Novartis Pharmaceuticals chronic lymphocytic leukemia (CLL)
Ceritinib[1] Novartis Pharmaceuticals anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC)
Idelalisib[1] Gilead Sciences relapsed chronic lymphocytic leukemia (CLL)
Ibrutinib[1] Pharmacyclics chronic lymphocytic leukemia (CLL) with 17p deletion
Eltrombopag[1] Novartis Pharmaceuticals aplastic anemia
Pembrolizumab[1] Merck metastatic melanoma
Ledipasvir/sofosbuvir[1] Gilead Sciences Hepatitis C
Pirfenidone[1] Genentech idiopathic pulmonary fibrosis
Nintedanib[1] Boehringer Ingelheim idiopathic pulmonary fibrosis
Blinatumomab[1] Amgen acute lymphoblastic leukemia
Ombitasvir/paritaprevir/ritonavir/dasabuvir[1] AbbVie Hepatitis C
Nivolumab[1] Bristol-Myers Squibb[1] metastatic melanoma
Ivacaftor[1] Vertex Pharmaceuticals cystic fibrosis with CFTR R117H mutation

2013

Drug Manufacturer Indication
Obinutuzumab[1] Genentech chronic lymphocytic leukemia
Ibrutinib[1] Pharmacyclics mantle cell lymphoma
Sofosbuvir[1] Gilead Sciences Hepatitis C

References

  1. ↑ 1.000 1.001 1.002 1.003 1.004 1.005 1.006 1.007 1.008 1.009 1.010 1.011 1.012 1.013 1.014 1.015 1.016 1.017 1.018 1.019 1.020 1.021 1.022 1.023 1.024 1.025 1.026 1.027 1.028 1.029 1.030 1.031 1.032 1.033 1.034 1.035 1.036 1.037 1.038 1.039 1.040 1.041 1.042 1.043 1.044 1.045 1.046 1.047 1.048 1.049 1.050 1.051 1.052 1.053 1.054 1.055 1.056 1.057 1.058 1.059 1.060 1.061 1.062 1.063 1.064 1.065 1.066 1.067 1.068 1.069 1.070 1.071 1.072 1.073 1.074 1.075 1.076 1.077 1.078 1.079 1.080 1.081 1.082 1.083 1.084 1.085 1.086 1.087 1.088 1.089 1.090 1.091 1.092 1.093 1.094 1.095 1.096 1.097 1.098 1.099 1.100 1.101 1.102 1.103 1.104 1.105 1.106 1.107 1.108 1.109 1.110 1.111 1.112 1.113 1.114 1.115 1.116 1.117 1.118 1.119 1.120 1.121 1.122 1.123 1.124 1.125 1.126 1.127 1.128 1.129 1.130 1.131 1.132 1.133 1.134 1.135 (PDF) CDER Breakthrough Therapy Designation Approvals Data as of December 31, 2021. U.S. Food and Drug Administration (FDA). https://www.fda.gov/media/95302/download.  This article incorporates text from this source, which is in the public domain.
  2. ↑ "FDA Grants Psilocybin Second Breakthrough Therapy Designation". https://www.medscape.com/viewarticle/921789. Retrieved 5 January 2020. 
  3. ↑ Research, Center for Drug Evaluation and (2020-10-08). "Breakthrough Therapy Approvals" (in en). FDA. https://www.fda.gov/drugs/nda-and-bla-approvals/breakthrough-therapy-approvals. 
  4. ↑ "COMPASS Pathways Receives FDA Breakthrough Therapy Designation for Psilocybin Therapy for Treatment-resistant Depression". COMPASS Pathways. October 23, 2018. https://www.prnewswire.com/news-releases/compass-pathways-receives-fda-breakthrough-therapy-designation-for-psilocybin-therapy-for-treatment-resistant-depression-834088100.html. 
  5. ↑ "FDA Puts 'Magic Mushroom' Ingredient on Fast Track for Depression Treatment". www.healthline.com. November 7, 2018. https://www.healthline.com/health-news/fda-looking-at-magic-mushroom-ingredient-to-treat-depression. 
  6. ↑ "NRX-101 for Maintenance of Remission From Severe Bipolar Depression in Patients With Suicidal Ideation | Clinical Research Trial Listing ( Bipolar Depression | Suicidal Ideation ) ( NCT03396068 )". https://www.centerwatch.com/clinical-trials/listings/225445/nrx-101-for-maintenance-of-remission-from-severe-bipolar-depression-in-patients-with-suicidal-ideation/. 
  7. ↑ "Breakthrough Therapy Approvals". FDA. 2020-10-08. https://www.fda.gov/drugs/nda-and-bla-approvals/breakthrough-therapy-approvals. 
  8. ↑ "Approval report". https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/DrugandBiologicApprovalReports/NDAandBLAApprovalReports/UCM494010.pdf. 
  9. ↑ "FDA Grants Breakthrough Therapy Designation for MDMA-Assisted Psychotherapy for PTSD". maps.org. August 26, 2017. https://maps.org/news/media/6786-press-release-fda-grants-breakthrough-therapy-designation-for-mdma-assisted-psychotherapy-for-ptsd,-agrees-on-special-protocol-assessment-for-phase-3-trials. 
  10. ↑ "Ecstasy as a Remedy for PTSD? You Probably Have Some Questions.". The New York Times. May 1, 2018. https://www.nytimes.com/2018/05/01/us/ecstasy-molly-ptsd-mdma.html. 
  11. ↑ https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761065Orig1s000AdminCorres.pdf [bare URL PDF]




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