Soon there may be a new option available to those patients seeking medical help for depression, but are leery of traditional antidepressants due to the laundry list of side effects that have been linked to them, or who have had previous difficult experiences with the first line treatments.
According to an article from Bloomberg News, H. Lundbeck has created an experimental antidepressant that may appeal to patients unhappy with the sexual, weight- and sleep-related side effects that can occur with existing antidepressant treatments.
The experimental drug is currently only known as LU AA21004. And, the Danish company reportedly said LU AA21004 showed statistically significant results in eight of 10 late-stage studies that will support regulatory filings in the U.S. and Europe this year. The drug addresses “a huge unmet need” as more than 40 percent of patients stop taking available medications because of side effects or because they don’t feel much better, Chief Executive Officer Ulf Wiinberg said in an interview in London.
The medicine has “almost a placebo-like side effect profile, with no negative impact on weight, sex or sleep,”Wiinberg said.
The new drug is likely to be prescribed as a second-line treatment for patients who don’t respond to or can’t tolerate cheaper generic options, he said. It will help Lundbeck, the Nordic region’s second-largest drugmaker, replace lost revenue from its best-selling Lexapro antidepressant, which went off-patent in the U.S. in March. Lexapro generated almost 8.5 billion kroner ($1.5 billion) in sales last year.
Detailed results from the late-stage studies of LU AA21004 will be released in June. Unlike existing treatments like Lexapro and Eli Lilly & Co.’s Prozac, which are known as selective serotonin-reuptake inhibitors, or Lilly’s Cymbalta, a serotonin-norepinephrine reuptake inhibitor, Lundbeck’s drug has a new mechanism of action as a multi-modal neurotransmitter.
That accounts for the better side effect profile, Anders Pedersen, head of the company’s research and development, said in a phone interview. In addition, no cardiovascular irregularity has been observed in patients taking the medicine, which will be important for the regulatory review, Wiinberg said.
Approval may come in the second half of next year, according to Jefferies International Ltd. analysts, coinciding with the patent expiration for Cymbalta, which had 2011 sales of $4.16 billion.
While SSRIs such as Lexapro and Cymbalta are unlikely to be replaced as first-line treatments, “this still leaves a potential multi-billion-dollar market opportunity for AA21004 if its profile proves to be sufficiently differentiated as a second- or third-line option,” Jefferies analysts said in a note to investors after Lundbeck’s May 14 announcement.
Lundbeck, which focuses on illnesses related to the central nervous system, has several other drugs in late-stage clinical trials, including treatments for psychosis, schizophrenia and stroke. It is also expecting European regulatory approval of nalmefene, an anti-alcoholism drug, later this year.