TGA approves Symbicort prn to treat mild asthma

Symbicort prn

Symbicort prn is now indicated to treat mild asthma flare-ups after an extended indication was approved by the TGA.

Symbicort Turbuhaler and Rapihaler are now listed on the Australian Register of Therapeutic Goods (ARTG) as an anti-inflammatory reliever to treat mild asthma flare-up.

The extended indication means the inhaled corticosteroid/long-acting beta agonist (ICS/LABA) can now be prescribed as needed for anti-inflammatory reliever (AIR) therapy to treat mild asthma in people aged 12 years and older. 

‘It’s a big shift,’ said Advanced Practice Pharmacist and asthma educator, Debbie Rigby. ‘Right now, any doctor can prescribe Symbicort as an anti-inflammatory reliever.’

Previously, Symbicort’s ARTG certification was limited to reliever plus maintenance therapy, or maintenance therapy alone, but the extended indication brings the drug’s potential use in Australia into line with the Global Initiative for Asthma (GINA) guidelines on asthma management.1

‘The evidence supports the use of AIR therapy,’ Ms Rigby said. ‘Recent trials, SYGMA and Novel START, show benefits, reducing the number of exacerbations compared to prn short-acting beta2 agonist (SABA) use, and reducing the total steroid exposure to the patient.’

Concern about the long-term effects of steroids was one reason people are not adherent to using their regular preventer therapy, according to Ms Rigby.

For quick relief of acute symptoms, Ms Rigby said the evidence showed Symbicort worked just as quickly as SABAs (i.e. Symbicort has a short onset of action), but that international and Australian guidelines still recommend a SABA (e.g. salbutamol) for asthma first aid.

While the extended indication for Symbicort isn’t reflected in current Australian guidelines (e.g. the Australian Asthma Handbook), Ms Rigby said the Handbook is under revision.

Symbicort’s extended indication was another opportunity for pharmacists to have a conversation with consumers about their asthma control, according to Ms Rigby. 

‘We know that many people who come into the pharmacy for their SABAs are not well controlled. There’s many reasons why they don’t use their preventers as prescribed, but pharmacists play a critical role, because we provide SABAs and we know there are many times when there is overuse.’

A recent study by the Woolcock Institute of over 400 Australians found that around 70% of respondents were classed as SABA over-users.2

‘People with mild asthma, who rely on over-the-counter SABAs, represent about 20% of the 441 people who died from asthma last year,’ Ms Rigby said.

Language in the Australian Asthma Handbook has changed from ‘asthma attacks’ to ‘asthma flare-ups’, a change Ms Rigby said pharmacists need to adopt for the benefit of their consumers.

‘Pharmacists need to help [consumers] understand they have a chronic disease with intermittent flare-ups. Pharmacists shouldn’t use “attack” as it just reinforces the misconception that they are only just sick at the time of the “attack,”’ she said.

When it comes to Symbicort, Ms Rigby said she expects it will gain PBS approval later this month, and that it could be downgraded from a Schedule 4 (S4) drug in the near future.

‘It had a positive PBAC (Pharmaceutical Benefit Advisory Committee) recommendation, so it’s highly likely it will be included on the PBS. Perhaps some time in the future it will be downgraded to S3 so pharmacists can provide it over the counter,’ she said. 

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  1. Global Initiative for Asthma. Pocket Guide for Asthma Management and Prevention. 2019. At:
  2. Azzi EA et al. Understanding reliever overuse in patients purchasing over-the-counter short-acting beta2 agonists: an Australian community pharmacy-based survey. August 2019. At: