AstraZeneca announced this week that it will discontinue the production of Pulmicort (budesonide) 100 and 200 µg/dose HFA (hydrofluoroalkane) pressurized metered-dose inhaler (pMDI) due to manufacturing issues related to technical aspects of the device, which prevents the ongoing manufacture of the product. This issue is not related to the active ingredient, budesonide, or any other AstraZeneca product, said the company in a Mar. 7, 2010 release. The manufacturing decision will take effect immediately; however, patients can continue using the Pulmicort pMDI 100 and 200 µg strength until their current supply is finished.
“We have exhausted all potential solutions in our efforts to continue supplying this medicine,” said David Smith, executive vice-president of global operations and IS at AstraZeneca. “The time required to fully resolve the technical issues is highly uncertain. We believe it is our responsibility to communicate our decision swiftly, as it is in the patient’s best interest to find an alternative medication as soon as possible.”
AstraZeneca said that Pulmicort pMDI is manufactured using product-specific processes and components, the combination of which is not used with any other AstraZeneca respiratory products, and therefore “represents a unique issue to Pulmicort pMDI.” Pulmicort pMDI is only approved in certain countries. Additional announcements from AstraZeneca will follow in countries where Pulmicort pMDI is approved to provide further guidance to patients and physicians.
The company says it is working closely with the appropriate regulatory authorities, healthcare professionals, and manufacturers of similar asthma medications, where appropriate, to ensure all patients continue to receive the appropriate alternative treatment. The company is advising patients that currently take Pulmicort pMDI to contact their physicians about alternative treatments. Healthcare professionals should review their patients’ needs and prescribe a suitable alternative medication.
Pulmicort is an inhaled anti-inflammatory glucocorticosteroid for initiation and maintenance treatment of bronchial asthma in infants, children, and adults. Pulimort is available in a range of formulations: Pulmicort Turbuhaler (dry-powder inhaler), Pulmicort pMDI (pressurized metered-dose inhaler, chlorofluorocarbon-free), and Pulmicort Respules (suspension for nebulization). The company said that other AstraZeneca respiratory products, including Pulmicort Turbuhaler, Pulmicort Respules, and Pulmicort Flexhaler are not affected because they use different devices or device components and should continue to be used where sold in accordance with approved prescribing information. Other AstraZeneca pMDI products, such as Symicort (budesonide/formoterol fumarate dihydrate) pMDI and Vannair (budesonide/formoterol) are also not affected.
In a separate press release, the drug-delivery company SkyePharma, which developed the formulation for Pulmicort pMDI using proprietary formulation technology, said that AstraZeneca’s decision to end production of Pulmicort pMDI is expected to lead to the termination of SkyePharma's agreements with AstraZeneca for the product.
"AstraZeneca's decision to cease manufacture of Pulmicort pMDI because of problems related to the device is disappointing,” said SkyePharma CEO Axel Müller, in a Mar. 7, 2011 release. “However, it is one of 12 approved and marketed products which use our technology and we anticipate continued progress in our pipeline of development products this year, including Flutiform, which is currently being assessed by European regulators.”