Sunosi: how long were the pivotal tox studies?

“Pivotal repeat-dose toxicity studies have been performed in mice (up to 3 months), rats (up to 6 months with a 3-month recovery period) and dogs (up to 12 months with a 13 weeks recovery period).”

“Pivotal repeat-dose toxicity studies have been performed in mice (up to 3 months), rats (up to 6 months with a 3-month recovery period) and dogs (up to 12 months with a 13 weeks recovery period).”

“Rats: In a pivotal 6-month repeat-dose toxicity study with a 3-month recovery period, daily oral doses of 29, 253 and 505 (reduced to 379 at study day 93 because of overt toxicity) mg/kg solriamfetol produced”