Table III.
Examples of cases of reformulation/repositioning found in the literature
| Drug (s) | Original indication | New indication | Original formulation | New formulation | Ref. |
|---|---|---|---|---|---|
| Amiodarone | Initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation and hemodynamically unstable ventricular tachycardia in patients refractory to other therapy. | – | Cordarone® (oral formulation) | Cordarone IV® (IV formulation) | (11) |
| Azelastine hcl | Use in patients with seasonal allergic rhinitis (SAR) and non-allergic vasomotor rhinitis (VMR) | – | Azelastine (Astelin® 0.1%) Bitter taste (Side effect) Saline (Excipient) | Astepro® 0.1% sucralose and sorbitol (Excipient) | (10) |
| Citalopram Escitalopram | Major depressive disorder (MDD) | – | Citalopram (Cipramil® or Celexa®) Racemic mixture | Escitalopram (Cipralex® or Lexapro®) Single enantiomer version | (9, 12) |
| Cyclosporine A | Prophylaxis of graft rejection | – | Oral cyclosporine (Sandimmune SGC®) | Microemulsion oral formulation (Neoral®) | (13) |
| Efavirenz, emtricitabine and tenofovir diprovoxil fumarate (Atripla®) | HIV | – | Efavirenz, emtricitabine (available individually or in combination with tenofovir diprovoxil fumarate) and tenofovir diprovoxil fumarate (available individually as or in combination with emtricitabine) | (efavirenz/emtricitabine/tenofovir) Atripla® | (14) |
| Mesalazine | Induction of clinical and endoscopic remission in patients with mild-to-moderate, active ulcerative colitis (UC) and for the maintenance of remission | – | Oral mesalazine (Asacol®) 400/800-mg tablets 2–3 times daily | MMX Mesalazine (Mezavant XL®) 1,200-ms tablets once daily using multi-matrix release (MMX) technology | (15) |
| Omeprazole Esomeprazole | Gastric, anti-secretory | – | Omeprazole (Losec® or Prilosec®) | Esomeprazole Nexium® Single enantiomer version | (9) |
| Paroxetine | Major depressive disorder (MDD) | – | Paxil® or Seroxat® immediate release formulation | Paxil CR® (extended- or controlled release formulations) | (9, 12) |
| Valproate | Epilepsy | – | Chrono® (Tablets) [not adapted to children] | Oral solution or syrup (immediate-release formulations, twice to three times daily) Chromosphere® (microspheres powder) modified release formulation | (16) |
| Venlafaxine | Major depressive disorder (MDD) | – | Effexor® immediate release formulation | Effexor XR® Extended Release formulation | (9, 12) |
| Crizotinib | Anaplastic large-cell lymphoma | Non-small-cell lung cancer (NSCLC) | – | – | (1) |
| Duloxetine | Major depressive disorder (MDD) | Stress urinary incontinence (SUI) Yentreve® in Europe | – | – | (1, 5) |
| Fibromyalgia; | (1, 5) | ||||
| Chronic Musculoskeletal pain | (1, 5) | ||||
| Maintenance treatment of MDD; | (5) | ||||
| General Anxiety Disorder (GAD) | (5) | ||||
| Maintenance treatment of GAD; | (5) | ||||
| Everolimus | Immunosuppression | Pancreatic neuroendocrine tumours | (1) | ||
| Finasteride | Benign Prostatic Hyperplasia (BPH) | Male Pattern Baldness (MPB) | Proscar® 5 mg tabs | Propecia® 1 mg tabs | (17) |
| Desloratadine | Allergies | – | Loratadine (Lorastine® or Claritin®) | Desloratadine (Clarinex®, NeoClarityn® or Aerius®) Active metabolite of loratadine | (9) |
| Bromocriptine (Parlodel® -Cycloset®) | Parkinson's disease, hyperprolactinaemia and galactorrhoea | Diabetes mellitus (T2DM) | Standard release (Parlodel®) | Quick release (qr) (Cycloset®) | (7) |
| Hydralazine and isosorbide dinitrate | Hypertension vasodilator | Heart failure | 25, 50 mg tab (hypertension) 20 mg tab (vasodilator) | 37.5/20 mg tab | (5) |
| Minoxidil | Hypertension | Male pattern baldness (MPB) | Tablet | Topical use | (1, 7, 18) |
| Paclitaxel | Cancer chemotherapeutic agent | Prevention of restenosis of coronary stents | – | A unique form of delivery (stent elution) | (5) |
| Imatinib | Chronic Myeloid Leukemia (CML) | Gastrointestinal stromal tumor (GIST) | – | – | (1, 3, 17, 18) |
| Ischaemic stroke | – | – | (1, 3, 17, 18) | ||
| Rheumatoid arthritis | – | – | (1, 3, 17, 18) | ||
| Psoriasis | – | – | (1, 3, 17, 18) | ||
| Crohn's disease | – | – | (1, 3, 17, 18) | ||
| Type I diabetes | – | – | (1, 3, 17, 18) | ||
| Spondyloarthritis | – | – | (1, 3, 17, 18) | ||
| Paclitaxel | Cancer chemotherapeutic agent | Treatment of metastatic breast cancer | – | – | (18) |
| Sildenafil | Angina (failed clinical trials) | Erectile dysfunction | – | – | (1, 4, 7, 17–21) |
| Erectile dysfunction | Pulmonary arterial hypertension | 50–100 mg tabs | 20 mg tabs | (1, 19) | |
| Sunitinib | GIST, renal cell carcinoma | Pancreatic neuroendocrine tumors | – | – | (1) |
| Thalidomide | Prescribed to pregnant women for preventing morning sickness (withdrawn) | Erythema Nodosum Leprosum (ENL) | – | – | (1, 5, 7) |
| Multiple myeloma | – | – | (1, 5, 7) | ||
| Trastuzumab | HER2-positive breast cancer | HER2-positive metastatic gastric cancer | – | – | (1) |
Repositioning and reformulation cases that were cited in the results section are presented in this table with details including the indication and formulation of the original product and the new indication and/or formulation.