Takeda’s dependence-free sleeping pill approved
pharmafile | September 2, 2005 | News story | Research and Development, Sales and Marketing |Â Â Â
A new sleeping pill which patients cannot abuse or become dependent on has been approved in the US.
Takeda's Rozerem (ramelteon) is the first sleeping medication not to be designated a controlled substance by US authorities and is the first insomnia treatment with a new therapeutic mechanism in 35 years.
The company expects the new drug safer profile, which allows it to be prescribed for long-term use, will help it hit peak sales in excess of $500 million.
But Rozerem is just one of a wave of new products in the therapeutic area, with Sanofi-Aventis and Pfizer both preparing to launch major new competitors in the coming months.
Rozerem's launch is a major one for Takeda, and the company hopes to tap into a market of an estimated 60 million people in the US who suffer from insomnia, although the vast majority of these remain undiagnosed and untreated.
"People with insomnia are not only affected by their sleeplessness at night; insomnia impact is also in how they feel and function the next day," said Thomas Roth director of the Sleep Disorders and Research Center, Detroit.
Current therapies often used for insomnia work by broadly inhibiting the activity of neurons in the brain. Ramelteon treats insomnia by specifically affecting the activity of neurons in an area of the brain involved in the sleep-wake process, and has been shown to carry no risks of abuse, withdrawal, or dependency, and negligible risk for next-day 'hangover'effects.
Rozerem's unique mode of action selectively targets two receptors located in the brain suprachiasmatic nucleus (SCN). The SCN is known as the body aster clockbecause it regulates 24-hour, or circadian, rhythms including the sleep-wake cycle.
The US approval was based on clinical studies with more than 4,200 adult patients, with 472 patients receiving single daily doses of Rozerem for up to one year. Trials have also shown the drug to be safe for target groups including older adults, and those who have mild-to-moderate chronic obstructive pulmonary disease (COPD) and mild-to-moderate sleep apnoea.
Rozerem should not be used by patients with severe hepatic impairment, or in patients in combination with fluvoxamine.
The most common adverse events seen with the drug were somnolence, dizziness, and fatigue. The drug has also been associated with decreased testosterone levels and increased prolactin levels, and healthcare professionals have been told to be mindful of any unexplained changes associated with changes in hormone levels.
In April 2005 the small US pharma company Sepracor launched Lunesta, the first sleeping pill approved without a restriction on the duration of its use, although initial prescribing will be limited.
Unlike Rozerem, however, the drug is still classed as a controlled substance, and many analysts believe it will struggle to compete with the brands launched by the bigger players.
Sanofi-Aventis Ambien (known as Stilnoct in the UK) is the world biggest-selling sleep treatment with sales of E670 million in the first half of 2005. A new controlled release version of the drug is currently awaiting final clearance from the FDA, but will face a challenge not only from Rozerem but Indiplon, another new rival from Pfizer and biotech partners Neurocrine Biosciences.
Indiplon was accepted for filing by the FDA in July, and could be on the market by early 2006.
The drug is a unique non-narcotic, non-benzodiazepine agent that acts on a specific site of the GABA-A receptor and is similar to Ambien.
But its co-developers say it offers superior results in patients addressing a pectrum of different insomnia complaintscurrently not adequately treated.
Finally, another potential competitor, gaboxadol, is being developed by Merck and Lundbeck, but is not expected to hit the market before late 2006 or 2007.
