Notice: Prescription Drug List (PDL): Mometasone furoate monohydrate

November 27, 2014
Our file number: 14-114626-838

The purpose of this Notice of Consultation is to provide an opportunity to comment on the proposal to revise the listing for Adrenocortical hormones on the Prescription Drug List (PDL) to allow the nonprescription use of Mometasone furoate monohydrate for the conditions listed below. Only the human part of the PDL is proposed to be revised. The proposed wording of the new listing is:

Drugs containing the following: Adrenocortical hormones or their salts or derivatives

Including (but not limited to): Hydrocortisone, Hydrocortisone acetate, Hydrocortisone valerate, Hydrocortisone sodium succinate, Clobetasone butyrate, Difluprednate and Mometasone furoate monohydrate

Qualifier: Mometasone furoate monohydrate for the treatment of allergic rhinitis in a nasal spray that delivers 50 micrograms (mcg)/spray for those 12 years of age and older.

Effective Date: to be determined

Rationale:

Mometasone furoate monohydrate (MF) was approved and first marketed in Canada in 1998 for the treatment of the symptoms of perennial allergic rhinitis (PAR) and seasonal allergic rhinitis (SAR) unresponsive to conventional treatment in adults and adolescents 12 years and older. MF was subsequently approved for the treatment of allergic rhinitis for children between the ages of 3 and 11 years of age in 1999. Additional approvals received for MF spray include:

1. adjunctive treatment to antibiotics for acute episodes of sinusitis in adults and children 12 years of age and older in 2000;
2. to treat the symptoms of nasal polyposis in adults 18 years of age and older in 2006; and
3. to treat the symptoms associated with acute rhinosinusitis in patients 12 years of age and older without signs or symptoms of severe bacterial infections in 2008.

Allergic rhinitis (SAR and PAR) is a disease that can be easily self-diagnosed by consumers. However, not all patients respond to second generation oral antihistamines, the most common nonprescription treatment available. According to the guidelines of the Canadian Rhinitis Working Group, intranasal corticosteroids are considered the most effective monotherapy for treatment of allergic rhinitis symptoms because they target a wider range of symptoms than the other pharmacotherapies. Labelling reinforces the need to seek health professional advice if the symptoms are persistent or worsening after a treatment of 7 days. The safety of short term use of corticosteroids in the treatment of allergic rhinitis is well established.

In conclusion, none of the criteria outlined in section C.01.040.3 of the Food and Drug Regulations apply to Mometasone furoate monohydrate when sold for human use for the treatment of PAR and SAR in a nasal spray that delivers 50 mcg/spray for those 12 years of age and older.

Additional information on how Health Canada determines prescription status (or non-prescription status) is available in the Guidance Document: Determining Prescription Status for Human and Veterinary Drugs.

Please send your comments to:

Health Canada
Prescription Drug Status Committee
Address Locator 3102C3
Holland Cross, Tower B
1600 Scott Street
Ottawa, Ontario
K1A 0K9

Telephone: 613-957-1058
Facsimile: 613-941-5035
E-mail: drug_prescription_status-statut_d'ordonnance_des_drogues@hc-sc.gc.ca

If all comments not in favour of this change can be addressed, a Notice of Intent to Amend will be posted on the Health Canada website. This Notice will address these comments and inform stakeholders of Health Canada's intention to revise the PDL. The actual revision to the PDL would be made six months from the date of the Notice of Intent to Amend and communicated to stakeholders through a Notice of Amendment.