Editors' (re)View: Intra-Cellular depression drug nears regulatory submission; Eli Lilly targets counterfeiters

June 21, 2024
Pharma Manufacturing editors Karen Langhauser and Andrea Corona comment on the notable happenings in the pharma industry from the week of June 17

Intra-Cellular depression drug nears regulatory submission

Intra-Cellular Therapies announced positive results from their second phase 3 trial, Study 502, this week, testing lumateperone 42 mg as an add-on treatment for major depressive disorder (MDD).

The trial showed significant improvements, supporting their upcoming application to the FDA, expected later this year.

The study found that lumateperone 42 mg, when added to regular antidepressants, reduced depression scores by 4.5 points more than a placebo after six weeks. It also improved overall illness severity early on, maintaining these benefits throughout the study.

Patients reported feeling better with fewer depressive symptoms, according to the Quick Inventory of Depressive Symptomatology Self-Report. These results, combined with previous findings from Study 501, strongly support lumateperone as a promising option for MDD patients.

Treatment for MDD typically involves medications, therapy and lifestyle changes. Common medications include SSRIs and SNRIs, with alternatives like atypical antidepressants. Despite the availability of various antidepressants, many patients do not achieve full remission or experience significant side effects, highlighting the limitations of current therapies.

In 2019, J&J’s Spravato became the first new drug approved to treat depression in more than 30 years when it was approved in conjunction with an oral antidepressant for treatment-resistant depression. A year later, it was approved for use as an add-on to treat MDD with acute suicidal ideation and behavior. 

Now, several drugs for MDD are currently in late-stage trials. Zuranolone from Sage Therapeutics and Biogen, and Seltorexant from Janssen Pharmaceuticals are notable examples that have yielded positive results in their respective trials. The drugs target different mechanisms to offer new hope for patients not responding to existing treatments.

J&J has also reported positive topline results from a post-marketing surveillance study of its esketamine nasal spray, Spravato, as a monotherapy in patients with treatment-resistant depression. 

Developing innovative treatments that can target the underlying biological mechanisms of MDD more precisely could revolutionize care, improve patient outcomes and alleviate the extensive impact of the debilitating disorder. — Andrea Corona

Fake weight loss drugs are dangerous and Eli Lilly is going after bad actors

This week, Eli Lilly posted an open letter outlining the risks posed by counterfeit and illegally compounded versions of its FDA-approved tirzepatide medications.

As part of the effort, the drugmaker says it is filing several legal actions against med spas, wellness centers and other entities selling unapproved compounded products containing what they claim is tirzepatide. (A concerning quote from Lilly: “"Lilly does not know where compounding pharmacies or other sellers are obtaining the tirzepatide active ingredient they are selling.")

Eli Lilly says it has discovered compounded drugs advertised as tirzepatide with safety, sterility and efficacy problems. “Some have contained bacteria, high impurity levels, different colors (pink, instead of colorless), or a completely different chemical structure than Lilly’s FDA-approved medicines.”

The lawsuits follow a series of suits filed by the drugmaker last fall as well as similar lawsuits filed by competitor Novo Nordisk.

With over 40% of the U.S. adult population suffering from obesity, people are desperate to get their hands on these new weigh loss drugs. In some cases, their lives might depend on it. The combination of high unmet need, spotty payer coverage and low supplies has created the perfect storm for counterfeiters.

And let’s not forget that the pharma industry still has an image problem — weight loss drug prices are exorbitant, and the public views the pharma industry as greedy. Finding a ‘loophole’ to obtain drugs at a much lower price point could be viewed as a way to show up big pharma, health risks be damned.

In my tenure as pharma journalist, I’ve found that there is a public knowledge gap when it comes to understanding the difference between branded and generic drugs and the FDA approval process in general, so I appreciate when pharma companies attempt to educate their potential patients. While I understand that it is in Lilly’s best interest to squash counterfeit versions of its branded drugs, the company has made an effort to explain the very real risks of illegally compounded drugs — now let’s just hope the public is willing to listen. —Karen Langhauser

About the Author

Karen P. Langhauser | Chief Content Director, Pharma Manufacturing

Karen currently serves as Pharma Manufacturing's chief content director.

Now having dedicated her entire career to b2b journalism, Karen got her start writing for Food Manufacturing magazine. She made the decision to trade food for drugs in 2013, when she joined Putman Media as the digital content manager for Pharma Manufacturing, later taking the helm on the brand in 2016.

As an award-winning journalist with 20+ years experience writing in the manufacturing space, Karen passionately believes that b2b content does not have to suck. As the content director, her ongoing mission has been to keep Pharma Manufacturing's editorial look, tone and content fresh and accessible.

Karen graduated with honors from Bucknell University, where she majored in English and played Division 1 softball for the Bison. Happily living in NJ's famed Asbury Park, Karen is a retired Garden State Rollergirl, known to the roller derby community as the 'Predator-in-Chief.' 

About the Author

Andrea Corona | Senior Editor

Andrea Corona serves as the Senior Editor of Pharma Manufacturing — a leading source of news and insights for pharma professionals — and is responsible for creation of editorial content, moderating webinars, and co-hosting the "Off script" podcast. Her editorial journey started as an as associate editor at Biocompare, an online platform providing product information, industry news, articles, and other resources to support scientists in their work. Before Biocompare, she was a digital producer at Science Friday, focusing on adapting radio segments for the web and social media management. Andrea earned her bachelor's degree in journalism and biology from the State University of New York, at Purchase College.