Targeted topical therapy for chronic anal fissure
ANOSOFT-NL Cream
Nifedipine 0.3% + lidocaine 1.5% rectal cream
ANOSOFT-NL combines 0.3% nifedipine, a topical calcium-channel blocker, with 1.5% lidocaine, a local anaesthetic, in a single rectal cream.Nifedipine acts locally to reduce internal anal sphincter tone, addressing a key physiological component associated with chronic anal fissure. Lidocaine provides local anaesthetic action to help relieve fissure-associated pain.
Clinical Problem
An unmet need in chronic anal fissure
Chronic anal fissure is painful, distressing and often slow to heal. Although glyceryl trinitrate (GTN) is a licensed topical treatment, no new medical therapy has been introduced for this condition in the UK in the past 20 years.
GTN may cause headaches in up to around 30% of patients, which can limit tolerability, and healing rates remain modest. Calcium-channel blockers, such as diltiazem, are frequently used as an alternative. However, they are generally unlicensed or prescribed off-label and are often prepared extemporaneously by individual pharmacies, which may result in variation in formulation and consistency. Lateral internal sphincterotomy is effective but carries a risk of faecal incontinence.
There remains a clear need for an effective, well-tolerated topical treatment with minimal systemic effects
A growing evidence base for topical nifedipine
The evidence supporting topical nifedipine in the medical management of anal fissure has been strengthened by a 2025 systematic review and network meta-analysis of 22 randomised controlled trials involving 1,770 patients.
“Nifedipine demonstrated the highest healing rate among the pharmacological treatments evaluated in a network meta-analysis of 22 RCTs involving 1,770 patients.”
Click Here for the study link
Dual action, one application
ANOSOFT-NL Cream combines two agents that address the fissure from both sides
Nifedipine 0.3%, treats the cause
A calcium channel blocker that relaxes the internal anal sphincter, lowering resting pressure and improving blood flow to the fissure. A reversible chemical sphincterotomy that supports healing without surgery.
Lidocaine 1.5%, treats the pain
A local anaesthetic that blocks sodium channels in local nerve endings for rapid symptomatic relief, particularly around defecation, supporting adherence to the full course.
Evidence
Direct evidence for the ANOSOFT-NL formulation
94.5% Healing Rate in RCT
Chronic anal fissure healing at six weeks, versus 16.4% with the comparator.
*Perrotti et al., Diseases of the Colon & Rectum, 2002 (randomised, double-blind; n=110)*
Highest healing rate in Systemic Review
Nifedipine ranked first among topical agents in a pooled analysis of 22 randomised trials.
*Wang et al., network meta-analysis, 2025*
No systemic effects
No systemic side effects were observed in the nifedipine-lidocaine group in the pivotal trial.
*Perrotti et al., 2002*
Lower headache burden
Unlike nitrates, associated with headache in up to around 30% of patients, this is not associated with nitrate-type headache.
*NHS treatment guidance*
*Source: NHS treatment guidance on anal fissure
Comparison
Treatment Landscape
Chronic anal fissure is managed with topical agents, injection, or surgery. The table sets out the main options for comparison. Figures are drawn from published trials and UK prescribing guidance; see references.
*SUCRA stands for Surface Under the Cumulative Ranking Curve. It is a statistic used in a network meta-analysis to rank several treatments for a particular outcome, using both direct and indirect comparisons between studies.
Guideline support
Guideline support
The 2023 Italian Unitary Society of Colon-Proctology (SIUCP) guideline, developed using the GRADE methodology, recognises topical calcium-channel blockers as an established non-surgical treatment option for chronic anal fissure.
The guideline specifically identifies 0.3% nifedipine + 1.5% lidocaine among the topical treatments that may be considered in the management of anal fissure.
Acute thrombosed external haemorrhoids
A prospective randomised trial involving 98 patients compared 0.3% nifedipine + 1.5% lidocaine with 1.5% lidocaine alone in acute thrombosed external haemorrhoids.
Complete pain relief at seven days was reported in 86% of patients receiving nifedipine/lidocaine compared with 50% receiving lidocaine alone. Resolution of the thrombosed haemorrhoid at 14 days was reported in 92% versus 45.8%, respectively.
The 2024 SIUCP guideline on haemorrhoidal disease also discusses topical 0.3% nifedipine + 1.5% lidocaine as a conservative treatment option for selected patients with thrombosed or strangulated haemorrhoids.
Post-haemorrhoidectomy pain
A multicentre, prospective, randomised, double-blind trial involving 270 patients evaluated 0.3% nifedipine + 1.5% lidocaine following haemorrhoidectomy.
Compared with 1.5% lidocaine alone, the combination demonstrated significantly better pain control at six hours post-operatively (p<0.011), with a favourable but non-significant trend at day seven (p<0.054).
These studies provide supportive evidence for the combination in selected anorectal conditions. However, they should be regarded as secondary evidence and should not be presented as promotional indications unless they are specifically covered by the product's applicable Marketing Authorisation and SmPC.
Supporting Evidence in Other Anorectal Conditions
Evidence has also investigated 0.3% nifedipine + 1.5% lidocaine in selected anorectal conditions beyond chronic anal fissure.
Details
Clinical perspective
Taken together, the evidence provides support at both the class level and formulation level:
The 2025 network meta-analysis provides contemporary comparative evidence supporting nifedipine for fissure healing.
Randomised clinical evidence directly evaluates the 0.3% nifedipine + 1.5% lidocaine combination.
Contemporary clinical guidelines recognise topical calcium-channel blockade as an important non-surgical treatment approach for chronic anal fissure.
For appropriate adult patients with chronic primary anal fissure, ANOSOFT-NL Cream provides a topical nifedipine/lidocaine treatment approach supported by randomised clinical evidence, systematic review evidence and contemporary guideline recommendations.
For Pharmacists & Stockists
Prescribe/ stock ANOSOFT-NL Cream
For prescribing information, stocking enquiries, or to obtain ANOSOFT-NL, get in touch and our team will assist.
Reporting adverse events
If you suspect an adverse reaction, report it through the Yellow Card scheme at yellowcard.mhra.gov.uk. Adverse events can also be reported to us via email.
For Healthcare Professionals Only
This section of the Anosoft website is intended exclusively for UK healthcare professionals and authorised prescribers.
The information provided is for professional reference and is not intended for patients or the general public. It should be considered alongside the relevant prescribing information and does not replace independent clinical judgement.
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