{
 "query": "trospium / xanomeline",
 "ingredient": "trospium / xanomeline",
 "slug": "trospium-xanomeline",
 "rxcui": "2694836",
 "brands": [
  "Cobenfy"
 ],
 "names": [
  "trospium / xanomeline"
 ],
 "components": [
  {
   "ingredient": "trospium",
   "slug": "trospium",
   "grade": "A",
   "total": 88,
   "scores": {
    "safety": "A",
    "evidence": "D",
    "regulatory": "A",
    "conflict": "A",
    "options": "A"
   },
   "boxed": false,
   "controlled": false,
   "first_approval_fmt": "05/28/2004",
   "first_approval": "20040528"
  },
  {
   "ingredient": "xanomeline",
   "slug": "xanomeline",
   "grade": "B",
   "total": 79,
   "scores": {
    "safety": "A",
    "evidence": "F",
    "regulatory": "A",
    "conflict": "A",
    "options": "F"
   },
   "boxed": false,
   "controlled": false,
   "first_approval_fmt": "",
   "first_approval": ""
  }
 ],
 "classes": [],
 "alternatives": [],
 "label": {},
 "faers": null,
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [],
 "recall_total": 0,
 "drugsfda": {
  "first_approval": "20040528",
  "first_approval_fmt": "",
  "anda": 0,
  "nda": 0,
  "rems": false,
  "labeling_recent": 0
 },
 "trials": null,
 "pubmed": null,
 "payments": {
  "year": "2024",
  "usd": 2537068.13,
  "records": 15852,
  "by_name": [
   [
    "Cobenfy",
    2537068.13
   ]
  ],
  "names_checked": [
   "trospium / xanomeline",
   "Cobenfy"
  ],
  "source": "bulk-index"
 },
 "partd": null,
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": null,
 "exposure": null,
 "scores": {
  "safety": {
   "score": 100,
   "letter": "A",
   "why": [
    "Graded by its riskiest ingredient, trospium (100)",
    "1,606 FDA reports naming it as the suspect drug per million Medicare fills, 0.6x the median drug on this site",
    "Death share in reports is near or below the FAERS average (0.9x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 40,
   "letter": "F",
   "why": [
    "Graded by its riskiest ingredient, xanomeline (40)",
    "15 randomized trials and 8 systematic reviews/meta-analyses indexed in PubMed",
    "No Cochrane review found (-5)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 99,
   "letter": "A",
   "why": [
    "Graded by its riskiest ingredient, trospium (99)",
    "Recalls since 2016: 0 Class I, 1 Class II, 0 Class III across 12 generic makers (-1)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 70,
   "letter": "C",
   "why": [
    "Graded by its riskiest ingredient, trospium (100)",
    "Pharma paid doctors $0 tied to this drug last year: negligible",
    "Not named in any pending federal MDL",
    "For the combination product itself:",
    "Pharma paid doctors $2,537,068 tied to this drug last year (-30)",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 40,
   "letter": "F",
   "why": [
    "Graded by its riskiest ingredient, xanomeline (40)",
    "No generic version approved: brand-only pricing (-30)",
    "No same-class alternatives found: little leverage to switch (-30)"
   ],
   "weight": 0.1
  }
 },
 "total": 74,
 "grade": "C",
 "questions": [
  "This is a fixed combination of trospium and xanomeline. Why both together, instead of only the one I need?",
  "The most-reported problems in FDA's adverse event data are fall, fatigue, urinary tract infection. How would we recognize and handle those?",
  "Why this one over darifenacin, emepronium, fesoterodine? What would make you pick one of those instead?",
  "What result are we expecting, by when, and what is the plan if it does not happen?",
  "If 100 people like me took this drug, how many would actually get better because of it, and how many would be harmed by it? (Doctors call these the number needed to treat and the number needed to harm.)",
  "The most-reported problems in FDA's adverse event data are akathisia, weight increased, blunted affect, cognitive disorder. How would we recognize and handle those?",
  "There is no generic. Is there an older generic in the same class that works as well for my situation?"
 ]
}