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Finasteride Compassionate Use and Expanded Access: How to Get Finasteride Cheaper

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At a glance

  • Drug / finasteride 1 mg (Propecia) and 5 mg (Proscar)
  • Approval dates / 1 mg: 12/19/1997; 5 mg: 06/19/1992 [1][2]
  • Expanded access / Does not apply; finasteride is FDA-approved, not investigational [3]
  • Generics / 1 mg and 5 mg tablets are FDA-approved under many ANDAs
  • Prescription status / Prescription only; the 1 mg product is for men only [4]
  • Dosing / 1 mg once daily for hair loss; 5 mg once daily for BPH [4][5]
  • Approved forms / The FDA approval listing shows oral tablets only; no FDA-approved topical or injectable finasteride [1][2]

Does FDA compassionate use apply to finasteride?

Expanded access, sometimes called compassionate use, is the pathway FDA regulates under 21 CFR part 312, subpart I, for treatment use of investigational drugs [3]. Finasteride is not investigational. Propecia, the 1 mg tablet, is NDA 020788, first approved 12/19/1997. Proscar, the 5 mg tablet, is NDA 020180, approved 06/19/1992 [1][2]. Organon is the current holder of both [1][2]. Generic 1 mg and 5 mg tablets are also FDA-approved.

So there is no compassionate-use application to file. Propecia and Proscar are prescription-only products, and Propecia is for men only [4].

What the labels cover

The 1 mg tablet is indicated for male pattern hair loss in men only. Efficacy in bitemporal recession is not established, and it is not indicated for women [4]. The 5 mg tablet is indicated for symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate, to improve symptoms and reduce the risk of acute urinary retention and of surgery [5]. The 5 mg tablet is a BPH product, not a larger hair-loss tablet. The Proscar label also states that it is not approved for prevention of prostate cancer [5].

Labeled dosing is one tablet once daily at either strength. For Propecia, the label says daily use for three months or more is generally necessary before benefit is observed, and that withdrawal of treatment leads to reversal of effect within 12 months [4][5].

Safety points from the labels and studies

Neither Propecia nor Proscar has a boxed warning. Sexual side effects are the main trade-off. In three 12-month controlled trials (945 men on finasteride 1 mg, 934 on placebo), drug-related decreased libido was 1.8% vs 1.3%, erectile dysfunction 1.3% vs 0.7% and ejaculation disorder 1.2% vs 0.7%. Overall, 3.8% vs 2.1% reported one or more of these (p=0.04) [4]. A 2019 meta-analysis of 15 randomized placebo-controlled trials in 4,495 men treated for androgenetic alopecia found a relative risk of sexual dysfunction of 1.57 (95% CI 1.19 to 2.08) [6].

The Propecia postmarketing section lists depression, suicidal ideation and behavior, and sexual dysfunction that continued after discontinuation. The label states these reports are voluntary and that a causal relationship cannot reliably be established [4][7].

Pregnancy is a contraindication. The label identifies exposure to crushed or broken tablets as a risk to a male fetus, and says intact coated tablets prevent contact [4].

Frequently asked questions

Is finasteride available through FDA compassionate use?
No. Expanded access covers investigational drugs used for treatment [3]. Finasteride 1 mg has been approved since 12/19/1997 and the 5 mg since 06/19/1992, and both strengths are also available as FDA-approved generics [1][2].
Do I need a prescription for finasteride?
Yes. Propecia and Proscar are prescription-only products, and the 1 mg product is for men only [4].
Is there an FDA-approved topical finasteride?
No. The FDA approval listing for finasteride shows only oral tablets; there is no FDA-approved topical or injectable finasteride [1][2].
Does finasteride have a boxed warning?
No. Depression, suicidal ideation and persistent sexual dysfunction appear in the postmarketing section of the Propecia label, which says causality cannot reliably be established from voluntary reports [4][7].
What is the difference between the 1 mg and 5 mg tablets?
The 1 mg tablet (Propecia) is indicated for male pattern hair loss in men. The 5 mg tablet (Proscar) is indicated for symptomatic BPH [4][5].

References

  1. Drugs@FDA: FDA-Approved Drugs. Drugs@FDA: FDA-Approved Drugs
  2. Drugs@FDA: FDA-Approved Drugs. Drugs@FDA: FDA-Approved Drugs
  3. Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers | FDA. Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers | FDA
  4. U.S. National Library of Medicine, DailyMed. Propecia (finasteride 1 mg) tablets, Organon prescribing information. Propecia (finasteride 1 mg) tablets, Organon label
  5. U.S. National Library of Medicine, DailyMed. Proscar (finasteride 5 mg) tablets, Organon prescribing information. Proscar (finasteride 5 mg) tablets, Organon label
  6. Lee S, Lee YB, Choe SJ, Lee WS. Adverse Sexual Effects of Treatment with Finasteride or Dutasteride for Male Androgenetic Alopecia: A Systematic Review and Meta-analysis. Acta Derm Venereol. 2019;99(1):12-17. Adverse Sexual Effects of Treatment with Finasteride or Dutasteride for Male Androgenetic Alopecia: A Systematic Review and Meta-analysis
  7. U.S. Food and Drug Administration. U.S. Food and Drug Administration
Evidence overview for Finasteride Compassionate Use and Expanded Access: How to Get Finasteride Cheaper