Poland Gives Green Light To Switches From Teva and Polpharma
Executive Summary
Teva and Polpharma's OTC operations in Poland are set to received a boost with the approval of two switches by national medicines regulator URPL. Polish consumers can now get OTC access to additional treatments for hay fever and cough.
Poland’s national medicines regulator, URPL, has approved two prescription-to-OTC switches to give consumers in the country direct access to treatments for season allergic rhinitis and cough.
Consumers can now purchase without a prescription Polpharma’s Momester Nasal (mometasone furoate) and from 1 August Teva’s Flegamina Baby (bromhexine hydrochloride).
The switch of Polpharma’s Momester Nasal means Polish patients will be able to access for the first time without a prescription the corticosteroid memetasone to treat hay fever. The only other corticosteroid with OTC status in Poland indicated for relief of seasonal allergic rhinitis is beclomethasone.
Momester Nasal 50 mcg/actuation is indicated for use in patients aged 18 years and over who have been diagnosed with hay fever by a doctor. It treats the common symptoms of seasonal allergic rhinitis such as sneezing, runny, stuffy or itchy nose by reducing swelling and irritation of the nasal mucosa.
The recommended daily dose is two actuations in each nostril per day. Patients are warned not to use Momester Nasal for more than 1 month without consulting a doctor, and to speak to a healthcare professional if symptoms do not improve within 14 days.
Mometasone in the form of a nasal spray is available OTC in a number of European markets such as Finland, Sweden and Switzerland. The UK recently switched the ingredient with the approval of Bayer’s Clarinaze Allergy Control. (Also see "Bayer Launches Clarinaze Allergy Control Following Successful Rx-to-OTC Switch In UK" - HBW Insight, 19 Feb, 2019.)
Mometasone furoate remains prescription-only in the US, with Merck & Co’s Nasonex the leading branded product. It is indicated to treat allergic rhinitis in adults and children aged from two years. While Bayer acquired the OTC rights to Nasonex in a number of markets, including the UK and Australia, Merck retains US market rights, making a switch unlikely in the near future.
Teva's Flegamina Wins Approval
Alongside Momeseter Nasal, URPL has also approved the Rx-to-OTC switch of Teva’s Flegamina Baby, making the children’s cough treatment available without a prescription in the form of an oral solution. Flegamina Baby’s active ingredient, bromhexine hydrochloride, is already available OTC in Poland.
Flegamina Baby 2mg/ml is indicated to treat acute and chronic respiratory ailments with impaired expectoration and mucus removal in children aged from two to six years. Parents are advised to take their child to a doctor if there is no improvement in symptoms after five days of treatment.
The switch of Flegamina Baby will bolster Teva’s existing OTC offering in Poland under the Flegamina brand, which comprises three oral solutions and a tablet format to treat coughs in adults.
Polish TV ad for the Flegamina range
Bromhexine hydrochloride is available in almost all EU member states, with notable exceptions including Austria and the UK, where it is not currently available, as is the case in the US.