NIFEXINE (nifedipine/lidocaine hydrochloride) - Pain associated with chronic anal fissures

The clinical benefit (CB) of NIFEXINE (nifedipine/lidocaine hydrochloride) is low in the MA indication.

Considering:

• the low level of evidence of clinical efficacy: study with an acceptable methodology (randomised controlled trial), but single-centre (55 patients per group) with a questionable choice of comparator (combination of 1% hydrocortisone acetate and 1.5% lidocaine cream not recommended in routine practice and off-label). In addition, the benefit of lidocaine has not been demonstrated in this indication (see Cochrane review);
• the effect size on relevant healing but with an effect on pain relief that is inadequately established and without any clearly determined effect on recurrences,
• the absence of quality of life data;

the Committee deems that NIFEXINE 0.3 g/1.50 g (nifedipine/lidocaine hydrochloride) rectal cream provides no clinical added value (CAV V) in adults to relieve the pain associated with chronic anal fissures following the failure of the usual treatments for acute symptoms of anal fissure.