MAYNE Pharma expects to launch its novel combined oral contraceptive, Nextsetellis (14.2mg estretrol and 3mg drospirenone), in Australia by the middle of next year, after receiving approval from the Therapeutic Goods Administration (TGA).
In a statement to the Australian Securities Exchange (ASX), Mayne CEO, Scott Richards, noted Nextstellis was the first new hormonal contraceptive to be given the green-light in Australia in the last decade.
Under the approval, Nextstellis had been granted five years of market exclusivity.
"We are pleased to be introducing Nextstellis to the Australian market," Richards said.
"It had been 10 years since Australian women have had a new contraceptive hormone to consider with their doctor.
"Nextstellis offers an effective, safe and well-tolerated pill with excellent cycle control and has demonstrated low impact on certain parts of the body."
Welcoming the approval of the medication, sexual health expert, Dr Terri Foran, noted Nextstellis offered an "effective combined contraceptive".
"Combine oral contraceptives continue to be the most widely used method of hormonal birth control in Australia and every clinician knows that each woman responds differently to hormones," she said.
"This is why is it so important to have a range of contraceptive options, so we can individualise that choice.
"Having another estrogen, estetrol (E4) [option], opens up the possibility that more women will be able to find a combination that suits them."
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