Vanda Pharmaceuticals Announces FDA Update for supplemental NDA for HETLIOZ® in the Treatment of Insomnia

WASHINGTON, Feb. 5, 2024 -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) announced that on February 4, 2024, it received a notification from the U.S. Food and Drug Administration (FDA) stating that as part of its ongoing review of Vanda's supplemental New Drug Application (sNDA) for HETLIOZ® (tasimelteon) in the treatment of insomnia characterized by difficulties with sleep initiation, the FDA has identified deficiencies that preclude discussion of labeling and postmarketing requirements/commitments at this time. No deficiencies were disclosed by the FDA in the notification, and the FDA stated that the notification does not reflect a final decision on the information under review. In a letter to Vanda dated July 17, 2023, the FDA had assigned a Prescription Drug User Fee Act target date of March 4, 2024 for the completion of its review of the sNDA.

Vanda has extensively studied the efficacy of HETLIOZ® in the treatment of insomnia characterized by difficulties with sleep initiation. A Phase III, multi-center, placebo-controlled, 4-week trial evaluated patients with chronic primary insomnia. Two transient insomnia studies induced by phase advance of the sleep-wake cycle were also conducted with five-hour and eight-hour phase advance, which showed a significant effect the first night in improving sleep parameters... Vanda Pharmaceuticals' Press Release [PDF] - 

Somaxon and CJ CheilJedang : Silenor® Collaboration in South Korea

April 27, 2012 - Somaxon Pharmaceuticals, Inc. (Nasdaq: SOMX) and CJ CheilJedang Corporation announced that they have entered into an exclusive collaboration under which CJ CheilJedang will commercialize Silenor® (doxepin) for the treatment of insomnia in South Korea.

Under the terms of the agreements, Somaxon will receive an up-front payment of US$600,000. CJ CheilJedang will be responsible for regulatory submissions for Silenor and will have the exclusive right to commercialize Silenor in South Korea. Once Silenor is approved in South Korea, Somaxon will also be eligible to receive sales-based milestone payments as well as a royalty based on net sales of Silenor in South Korea. Somaxon will also supply CJ CheilJedang's requirements for commercial quantities of Silenor in South Korea at a separate transfer price... Somaxon Pharmaceuticals' Press Release -

Merck : Update on Development Program for Suvorexant, an Investigational Orexin Receptor Antagonist for the Treatment of Insomnia

Feb. 6, 2012 - Company Confirms Plans to File NDA for Suvorexant in 2012 -

Merck (NYSE:MRK), known as MSD outside the United States and Canada, provided an update on the development program for suvorexant, the company's investigational orexin receptor antagonist, which, if approved, will be a new mechanism for the treatment of insomnia. The two pivotal Phase III efficacy trials for suvorexant have been completed and, based on the positive results of these studies, Merck plans to file a New Drug Application (NDA) for suvorexant with the U.S. Food and Drug Administration (FDA) in 2012.

Both Phase III studies were multicenter, randomized, double-blind, placebo-controlled clinical trials that evaluated suvorexant compared to placebo in adult patients ages 18 years and older. The primary endpoint was change from baseline in subjective total sleep time and time to sleep onset, wake time after persistent sleep onset, and latency to onset of persistent sleep at one and three months. Merck plans to submit these data for presentation at major medical meetings later this year... Merck's Press Release -

EISAI RECEIVES APPROVAL TO MARKET INSOMNIA TREATMENT LUNESTA® IN JAPAN

January 18, 2012 - Eisai Co., Ltd. (Headquarters: Tokyo, President & CEO: Haruo Naito, “Eisai”) announced that it received approval from Japan's Ministry of Health, Labour and Welfare (MHLW) on January 18, 2012 to market Lunesta® (eszopiclone), a product the company has been developing in Japan, as a treatment for insomnia.

Lunesta, originally discovered and developed by Sunovion Pharmaceuticals Inc. (“Sunovion”; formerly Sepracor Inc., “Sepracor”; a U.S. subsidiary of Dainippon Sumitomo Pharma Co., Ltd.), has been marketed in the United States since April 2005. The agent was approved as the first insomnia treatment not to have restrictions on its length of use, and is widely used by individuals suffering from insomnia. Eisai has been pursuing the development of Lunesta since acquiring the exclusive rights to develop and market it in Japan from Sunovion (at the time known as Sepracor) in July 2007. The company submitted a marketing authorization application to the MHLW in November 2010.

Lunesta is a non-benzodiazepine type GABAA agonist that is believed to enhance GABA activity while exerting hypnotic and sedative effects. Results from clinical studies conducted in Japan and overseas demonstrated that the agent is effective in those patients who have trouble falling asleep or wake up often during the night, two major symptoms of insomnia. A distinctive feature of Lunesta is that patients do not experience clinically problematic issues such as dependency or carry-over effects or develop a tolerance (experience diminished efficacy) with long-term use... Eisai's Press Release -

Meda and Valeant Pharmaceuticals : Sublinox approved in Canada

July 25 2011 – The insomnia drug Sublinox (Edluar) has been approved in Canada. Meda and its partner Valeant expect to begin the launch in the fourth quarter 2011.


Sublinox will be marketed by the joint venture between Meda and Valeant, Meda Valeant Pharma Canada Inc. Meda has global rights to the drug and markets it in the USA since 2009 under the name Edluar. Orexo, who has developed the drug, is entitled to royalties on sales.


The approval is for short-term treatment of insomnia. Sublinox is based on Orexo's sublingual tablet technology. The drug is placed under the tongue where it rapidly disintegrates and the active substance zolpidem is absorbed through the oral mucosa... Orexo's Press Release - Meda's Press Release - Valeant's Press Release -

Somaxon and Paladin : Silenor® EX-US Collaboration

June 8, 2011 - Somaxon Pharmaceuticals, Inc. (NASDAQ:SOMX) and Paladin Labs Inc. (TSX:PLB) announced that they have entered into an exclusive collaboration under which Paladin will commercialize Silenor® (doxepin) for the treatment of insomnia characterized by difficulty with sleep maintenance in Canada, South America and Africa. According to IMS Canada, the value of the Canadian insomnia market, mainly comprised of zopiclone, exceeded $79 million in 2010 alone and has been growing at a 5 year CAGR of 10%.


Under the terms of the agreements, Somaxon will receive an up-front payment of US$500,000, and Paladin will purchase 2,184,769 shares of Somaxon's common stock for a purchase price of US$5 million. Once Silenor is commercialized in the licensed territories, Somaxon will also be eligible to receive sales-based milestone payments of up to US$128.5 million as well as a tiered double-digit percentage of net sales in the licensed territories. Paladin will be responsible for regulatory submissions for Silenor in the licensed territories and will have the exclusive right to commercialize Silenor in the licensed territories. Governance of the collaboration will occur through a joint committee structure... Somaxon's Press Release - Paladin Labs' Press Release -

IntelGenx : Positive Bioequivalence Study with Insomnia Thin Film

April 6, 2011 - IntelGenx Corp. (TSX VENTURE:IGX) (OTCBB:IGXT) ("IntelGenx") announced the completion of a pilot biostudy indicating that IntelGenx has developed a novel oral film, INT0020, that suggests bioequivalency to a leading branded product for the treatment of insomnia. INT0020 has been developed using IntelGenx' proprietary immediate release "VersaFilm" drug delivery technology.

IntelGenx' President and CEO Dr. Horst Zerbe commented, "We are very pleased to have successfully completed another human study with our thin films. Insomnia is a largely untapped, multi-billion dollar market and our insomnia product is based on one of the leading medications within its class and could represent a very large opportunity for us."

Dr. Zerbe added. "Insomnia is a great example of an indication where convenience and quick onset of action are important for the patient making this an ideal application for our VersaFilm delivery system. We have previously completed successful studies in the areas of migraine, erectile dysfunction, and bipolar disorder. We are extremely pleased to have added a fourth product to our already strong pipeline of pharmaceutical films with positive human pharmacokinetic data."... IntelGenx's Press Release -

ECR Pharmaceuticals : Zolpimist Oral Spray

February 2011 - ECR Pharmaceuticals Co., Inc., a subsidiary of Hi-Tech Pharmacal Co., Inc. (NASDAQ: HITK) announced the immediate availability of Zolpimist Oral Spray, a novel delivery system of the most widely prescribed sleep aid in the US, zolpidem tartrate. The Zolpimist Oral Spray unit contains 60 metered sprays and provides the flexibility of administering either a 5 or 10 mg dose of the zolpidem active ingredient. As with most prescription hypnotic agents, Zolpimist Oral Spray is federally classified as a CIV controlled substance. Zolpimist is only available by prescription.

Hi-Tech President and CEO David Seltzer indicated that "Zolpimist is a significant addition to ECR, our branded products subsidiary, and reflects our continuing commitment to build this segment of our business through the marketing of widely used, innovative products."

Steven Ratoff, the CEO of Novadel Pharma Inc., the developer of Zolpimist Oral Spray, said "we are pleased to have Zolpimist available in the U. S. marketplace." Over 79 million prescriptions are written annually in the US for sleep aid products... ECR Pharmaceuticals' Press Release - Novadel Pharma's Press Release -

Actavis : 180-day marketing exclusivity in the US for Zolpidem Tartrate extended-release tablets, USP 6,25mg CIV

19 OCT 2010 - Actavis has received approval from the FDA to market Zolpidem Tartrate Extended-Release Tablets, USP 6,25mg CIV in the United States. Distribution of the product has commenced.

As the first company to file an ANDA that contained a paragraph IV certification for Ambien® CR 6,25mg, Actavis has been awarded 180-day exclusivity to market this product.

Zolpidem Tartrate extended-release tablets 6,25mg, the generic equivalent of Ambien® CR 6,25mg by Sanofi-Aventis, had US sales of approximately USD129 million for the 12 months ending 30 June, 2010 (IMS Health data)... Actavis' Press Release -

Evotec : License and collaboration agreement with Jingxin Pharma for EVT 201

28 October 2010: Evotec AG (Frankfurt Stock Exchange: EVT, TecDAX) announced that it has entered into a license and collaboration agreement with Zhejiang Jingxin Pharmaceutical Co., Ltd ("Jingxin Pharma") for EVT 201, a novel potential treatment for insomnia. The agreement grants Jingxin Pharma exclusive rights to develop and market the drug candidate in China. In return, Evotec will receive a small upfront payment, together with commercial milestones and significant royalties.


Jingxin Pharma will initiate clinical trials with EVT 201 in China in 2011. All development costs will be borne by Jingxin Pharma. Evotec will have the right to reference clinical data produced by Jingxin Pharma to support potential further development of EVT 201 in other territories... Evotec's Press Release -

Transcept Pharmaceuticals : Preliminary Results From the Intermezzo(R) Highway Driving Study

Oct 19, 2010 - Transcept Pharmaceuticals, Inc. (Nasdaq: TSPT) announced its preliminary analysis of data from the recently completed Intermezzo(R) 3.5 mg (zolpidem tartrate sublingual tablet) highway driving study. Transcept is developing Intermezzo(R) for use as-needed for the treatment of insomnia when a middle of the night awakening is followed by difficulty returning to sleep. In the Intermezzo(R) New Drug Application (NDA), Transcept proposed to the U.S. Food and Drug Administration (FDA) that patients have at least four hours remaining in bed after dosing Intermezzo(R) in the middle of the night.

About the Intermezzo(R) highway driving study

The Intermezzo(R) highway driving study was a double-blind, randomized, placebo-controlled, four-way crossover study of 40 healthy volunteers designed to evaluate the safety profile of Intermezzo(R) with regard to next morning driving. The study evaluated standard deviation of lateral position (SDLP) in a highway driving lane, a surrogate measure for driving performance, as subjects drove an automobile 100 km, or 62 miles, on a public highway under normal traffic conditions for approximately one hour. Subjects performed test drives on placebo, zopiclone as a positive control taken at bedtime nine hours before driving, Intermezzo(R) taken three hours before driving, and Intermezzo(R) taken four hours before driving. Based on a review of the published literature, an SDLP change of 2.5 cm was specified in the protocol as the primary threshold of impairment for the purpose of performing the statistical analyses. In March 2010, the FDA informed Transcept that the statistical methodology proposed by Transcept, a symmetry analysis, was a reasonable approach to measure potential next morning driving impairment... Transcept Pharmaceuticals' Press Release -

Sunovion Pharmaceuticals Inc. : Company Name Change

October 12, 2010 - Sunovion Pharmaceuticals Inc. (Sunovion), formerly Sepracor Inc. (Sepracor), announced that it has formally changed its name. The change occurs on approximately the one year anniversary of the acquisition of Sepracor by Dainippon Sumitomo Pharma Co., Ltd. (DSP), an Osaka, Japan based pharmaceutical company. Sunovion integrates under one brand the distinct competencies of Sepracor and the former Dainippon Sumitomo Pharma America, Inc. (DSPA), the two U.S. operations of DSP.

“This is an exciting time for Sunovion Pharmaceuticals Inc. and we are poised to deliver on our vision to become a leading global pharmaceutical company known for scientifically-advanced products that improve the lives of patients”
“This is an exciting time for Sunovion Pharmaceuticals Inc. and we are poised to deliver on our vision to become a leading global pharmaceutical company known for scientifically-advanced products that improve the lives of patients,” said Mark Iwicki, President and Chief Operating Officer of Sunovion. “The meaning of Sunovion combines the strength of the sun with innovation and, for us, represents the start of a great new company. Launching our new corporate identity is a meaningful next step for our employees and partners who have contributed to our past success. We remain focused on our goal to grow our current brands and advance our pipeline candidates.”

In April 2010, DSPA, based in Fort Lee, N.J., merged into Sepracor consolidating DSP’s North American footprint in Marlborough, Mass. As Sunovion, the company will maintain corporate headquarters in Marlborough and critical R&D functions will continue in both Fort Lee and Marlborough. The company will maintain sales and marketing efforts for leading central nervous system and respiratory brands including LUNESTA.. [PDF] Sunovion Pharmaceuticals' Press Release - [PDF] Dainippon Sumitomo Pharma's Press Release -

EISAI : JAPANESE CLINICAL TRIALS CONFIRM SAFETY AND EFFICACY OF INSOMNIA TREATMENT SEP-190

September 15, 2010 - EISAI PLANS TO SUBMIT MAA IN FISCAL 2010 - Eisai Co., Ltd. (Headquarters: Tokyo, President & CEO: Haruo Naito, “Eisai”) announced that clinical studies conducted in Japanese patients with insomnia have confirmed the efficacy and favorable safety profile of SEP-190 (generic name: eszopiclone). Based on these results, Eisai plans to submit a marketing authorization application in fiscal 2010 seeking approval of the agent to the Japan’s Ministry of Health, Labour and Welfare.

A Phase II/III clinical study (Study 126) with SEP-190 was conducted in Japan in patients with primary insomnia, in addition to a Phase III study (Study 150) in patients with insomnia. Study 126 evaluated the efficacy of SEP-190 in 72 adult patients with primary insomnia through an overnight polysomnography (PSG) and subjective evaluation. Results showed that, compared with placebo, SEP-190 statistically significantly reduced latency to persistent sleep (LPS), as measured by a PSG, and sleep latency (SL), as measured by subjective evaluation, the study’s two primary outcome measures. Study 150 evaluated the long term safety of SEP-190 in 325 adult and elderly patients with chronic insomnia caused by a variety of factors. Results of the study confirmed that the agent has a favorable safety profile.
SEP-190 is a non-benzodiazepine type GABAA agonist (non-benzodiazepine sedative hypnotic) discovered and developed by Sepracor Inc.,... Eisai's Press Release -

SOMAXON PHARMACEUTICALS : SILENOR® CO-PROMOTION AGREEMENT WITH PROCTER & GAMBLE

August 25, 2010 − Somaxon Pharmaceuticals, Inc. (Nasdaq: SOMX) announced that Somaxon and Procter & Gamble (NYSE: PG) have entered into a co-promotion agreement for Silenor® (doxepin), a newly-approved treatment for insomnia characterized by difficulty with sleep maintenance.
Under the terms of the agreement, Somaxon and Procter & Gamble will co-promote Silenor with a combined 215 sales representatives in the U.S. market. Procter & Gamble’s professional health care sales force will promote Silenor to targeted primary care and other high-prescribing physicians.

Somaxon’s focus will be on specialists and other top-decile physicians who treat insomnia. In addition, Procter & Gamble will promote Silenor to targeted pharmacies and will provide supplemental managed care support services for Silenor. Somaxon has also granted Procter & Gamble a right of first negotiation relating to rights to develop and market Silenor as an over-the-counter medication in the U.S... [PDF] Somaxon Pharmaceuticals' Press Release -

Merck : Results Presented from Phase IIb Clinical Study of its Investigational Insomnia Therapy MK-4305

June 9, 2010 - Data Reported at SLEEP 2010 24th Annual Meeting of the Associated Professional Sleep Societies – Clinical results from a Phase IIb study showed that MK-4305, Merck's investigational dual orexin receptor antagonist, was significantly more effective than placebo (p inf. 0.005) in improving overall sleep efficiency at night one and at the end of week four in patients with primary insomnia. MK-4305 was generally well-tolerated in the study. Orexins are neuropeptides (chemical messengers) that are released by specialized neurons in the hypothalamus region of the brain and are believed to be an important regulator of the brain’s sleep-wake process. The data were presented for the first time at the SLEEP 2010 24th Annual Meeting of the Associated Professional Sleep Societies.

Phase III trials studying the efficacy and safety of MK-4305 in elderly and non-elderly insomnia patients are ongoing. Merck anticipates filing regulatory applications for MK-4305 in 2012.

"Since the discovery and characterization of orexin over the past decade as an important component of the sleep-wake system, Merck has been actively committed to discovering and developing potential interventions for sleep disorders that target the orexin receptors. We are encouraged by these phase II results showing positive effects of MK-4305 in patients with primary insomnia,”... Merck's Press Release -

Sanofi-aventis and Nichi-Iko Pharmaceutical : New Joint Venture for Generics in Japan

May 28, 2010 - Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) and Nichi-Iko Pharmaceutical Co., Ltd. (Nichi-Iko) (Osaka Stock Exchange and Nagoya Stock Exchange: NIK) announced that they have signed an agreement to establish a new joint venture, called sanofi-aventis Nichi-Iko K.K., in order to develop a generic business in Japan.
The new joint venture will be held at 51% by sanofi-aventis K.K. and at 49% by Nichi-Iko. In addition, sanofi-aventis will acquire 1,524,500 shares of Nichi-Iko, to be issued through a third-party allocation, and as a result will hold 4.66% of Nichi-Iko. Nichi-Iko is the leader and fastest growing generics company in Japan, with 2009 sales reaching 54.8 billion JPY - around 460 million Euros...

[...]



...As a first step, the joint venture will take over the marketing and distribution rights in Japan for the antiinsomnia agent Amoban (zopiclone) from sanofi-aventis K.K. AmobanTM sales reached 5.1 billion Yen - or 43 million Euros* in 2009. Nichi-Iko will ensure the promotion and distribution of AmobanTM through its large network of pharmacies, wholesalers and medical institutions... [PDF] Sanofi-aventis' Press Release - [PDF, Japanese] Nichi-Iko Pharmaceutical's Press Release -

SOMAXON : FDA APPROVAL OF SILENOR® (DOXEPIN) FOR THE TREATMENT OF INSOMNIA

March 18, 2010 − Somaxon Pharmaceuticals, Inc. (Nasdaq: SOMX) announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Silenor® (doxepin) for the treatment of insomnia characterized by difficulty with sleep maintenance.
Sleep maintenance difficulty, defined as waking frequently during the night and/or waking too early and being unable to return to sleep, is the most commonly reported nighttime symptom of insomnia. Silenor is approved for the treatment of both transient (short term) and chronic (long term) insomnia characterized by difficulty with sleep maintenance in both adults and elderly patients. In clinical trials, Silenor demonstrated maintenance of sleep into the 7th and 8th hours of the night, with no meaningful evidence of next day residual effects... [PDF] Somaxon Pharmaceuticals' Press Release -

Lupin : FDA tentative approval for Eszopiclone tablets

March 20, 2010 - Pharma Major, Lupin Limited announced that its U.S subsidiary, Lupin Pharmaceuticals, Inc. (LPI) has received tentative approval for the Company’s Abbreviated New Drug Application (ANDA) for Eszopiclone tablets, 1 mg, 2 mg and 3 mg from the U.S. Food and Drug Administration (USFDA).

Lupin’s Eszopiclone tablets are the AB-rated generic equivalent of Sepracor’s LUNESTA® tablets, indicated for the treatment of insomnia. The brand product had annual sales of approximately $761 million for the twelve months ended December 2009, based on IMS Health sales data... Lupin Pharmaceuticals' Press Release -

HiTech Pharmacal and NovaDel : Exclusive Agreement to Commercialize Sleep Aid in Oral Spray Form

Nov. 16, 2009-- Hi-Tech Pharmacal Co., Inc. (NASDAQ: HITK) announced the signing of an exclusive licensing agreement between Hi-Tech’s ECR Pharmaceuticals subsidiary and NovaDel Pharma, Inc., a drug development company, through which ECR obtained the rights to market zolpidem tartrate oral spray, 5mg per spray, in the United States and Canada. Under the terms of the agreement ECR paid NovaDel $3 million upon closing. In addition NovaDel will receive a royalty of up to 15% on net sales, and a milestone payment if net sales reach a specific level in a calendar year.


The product, branded “Zolpimist™“ will be marketed by ECR Pharmaceuticals, Hi-Tech’s branded prescription pharmaceutical company. Zolpimist™ is an FDA approved product that is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation, and will be available only by prescription. Zolpimist™ is the only approved sleep aid which contains zolpidem tartrate in an oral spray form. In October 2009, NovaDel received a Notice of Allowance from the United States Patent and Trademark Office for claims under U.S. Patent Application No. 10/671,715, related to Zolpimist™. Once issued, the patent will expire in 2018. ECR plans to launch the product in the United States in the first half of calendar 2010... Hi-Tech Pharmacal's Press Release - NovaDel's Press Release -

Mylan : FDA Approval for Additional Strength of Generic Restoril®

June 17 , 2009 - Mylan Inc. (NASDAQ: MYL) announced that its subsidiary Mylan Pharmaceuticals Inc. has received approval from the U.S. Food and Drug Administration (FDA) for its supplemental Abbreviated New Drug Application (ANDA) for Temazepam Capsules USP, 22.5 mg. This strength is in addition to Mylan's currently marketed 15 mg and 30 mg strengths of the product.

Temazepam Capsules are the generic version of Mallinckrodt's Restoril®, a sleep aid, which had total U.S. sales of approximately $6 million for the 12 months ending March 31, according to IMS Health. Mylan has begun shipping this product...

...

Mylan Inc., which provides products to customers in more than 140 countries and territories, ranks among the leading diversified generics and specialty pharmaceutical companies in the world. The company maintains one of the industry's broadest - and highest quality - product portfolios, supported by a robust product pipeline; owns a controlling interest in the world's third largest active pharmaceutical ingredient manufacturer; and operates a specialty business focused on respiratory and allergy therapies... Mylan's Press Release -