SUDA Pharmaceuticals Ltd (ASX: SUD) is an oro-mucosal drug delivery company that is reformulating medication into an oral spray to improve the bioavailability of administered medications. By delivering the drugs through the oral mucosa, the company has increased the bioavailability by up to 95 per cent. The company uses its unique platform technology, OroMist®, for reformulating existing billion-dollar drugs for oral delivery.
SUDA has recently announced an update on ZolpiMistTM clinical study results. The results demonstrated that ZolpiMistTM, SUDA’s lingual spray version of the insomnia drug Ambien, delivers sleep onset more rapidly than the tablet form of zolpidem based on efficacy and pharmacokinetics parameters. It is a welcome news for the patients looking for short-term treatment of insomnia.
SUDA’s marketing authorisation holder for ZolpiMistTM in the USA, Aytu BioScience, Inc. notified about the publication of the ZolpiMistTM clinical study results in the Journal of Pharmacy and Pharmacology. Aytu is a US-headquartered pharmaceutical company that focusses on the commercialisation of novel products, addressing unmet medical needs of patients. The company holds exclusive Canadian and the US rights to ZolpiMistTM.
As per Aytu’s Chief Executive Officer, Josh Disbrow, ZolpiMistTM oral spray is likely to present patients with a simple way and a more convenient form to achieve rapid sleep onset. He mentioned that for the first time, this study has established the clinical proof that supports the use of ZolpiMistTM in the short-term treatment of insomnia.
Overview of Clinical Study Results
The clinical study results defined a post-hoc analysis of data from the Phase III study of ZolpiMistTM. In the study, 43 adults (including 20 males and 23 females), were given 10m g and 5 mg doses of the oral spray ZolpiMistTM and the tablet formulations of zolpidem for the comparison.
ZolpiMistTM Achieves Blood Serum Therapeutic Threshold Faster
The commonly accepted blood serum therapeutic threshold for zolpidem is a blood plasma concentration of 20 nanograms per millilitre (ng/mL). It was found in the study that ZolpiMistTM achieved this threshold in a shorter time relative to the tablet zolpidem. On an average, for the 10 mg dose, the oral spray formulation achieved this threshold at 7 minutes while tablet zolpidem achieved it at 15 minutes. On the other hand, for the 5 mg dose, ZolpiMistTM achieved this threshold at 10.5 minutes while tablet zolpidem achieved it at 17.2 minutes.
ZolpiMistTM Succeeds in DSST Test
In the study, the Digit Symbol Substitution Test or DSST was utilized as an additional measure to quantify sedation. The DSST is an assessment of perceptual speed, attention, memory, visual scanning and motor speed. The results highlighted that the average time to realize a five-point change (from baseline) in DSST for the 10 mg dose was 4.8 minutes for ZolpiMistTM and 14 minutes for tablet zolpidem. Besides, the average time to achieve a five-point change for the 5 mg dose was 8.0 minutes for ZolpiMistTM and 16.2 minutes for tablet zolpidem.
ZolpiMistTM Results in Increased Bioavailability
It was ascertained in the study that the oral tablet formulation of zolpidem tartrate subjects a drug to a first-pass metabolism effect and is relatively slow in comparison to ZolpiMistTM. This is so because when pills and tablets are swallowed, they are subject to degradation in the acid of the gut and are then metabolised by the liver, resulting in up to 90 per cent of the drug not available to treat the disease. However, when the drugs are delivered through the oral mucosa, they reach directly into the blood, preventing first-pass metabolism effects of the gut wall and liver.
Due to the first-pass metabolism effect, the bioavailability of the oral tablet formulation is generally low and slow. As a result, ZolpiMistTM oral spray allows over two-fold quicker onset of sedation relative to the zolpidem tablet formulation.
More on Insomnia Drug – ZolpiMistTM
ZolpiMistTM, the USFDA approved first-in-class lingual spray formulation of zolpidem tartrate for insomnia, offers advantages like ease of use without a need for water, and reduced sleep patient convenience. The patients suffering from gastrointestinal (GI) disorders or those experiencing difficulties in swallowing can benefit from using ZolpiMistTM, as per the company.
The company has three licence and supply agreements for ZolpiMistTM as follows:
- Eddingpharm: SUDA’s first licensee, Eddingpharm has an agreement with the company for the exclusive sale and distribution of the oral spray ZolpiMistTM in mainland China.
- Teva Pharmaceuticals: SUDA signed its second licensing agreement with Teva in July 2017. Under the agreement, SUDA granted Teva a licence to its product, ZolpiMistTM in Brazil, Mexico and Chile. An 18-month option was also provided to Teva to license ZolpiMistTM in Israel, Argentina and Australia.
- Mitsubishi Tanabe Pharma: In late December 2018, the company also entered into an agreement with a major pharmaceutical company, Mitsubishi Tanabe Pharma Singapore Pte Ltd for ZolpiMistTM. The agreement provided an exclusive licence to Mitsubishi Tanabe for the supply of ZolpiMistTM in Singapore, Philippines and Malaysia, along with a 12-month option period for Cambodia, Thailand, Vietnam, Brunei, Indonesia, Laos and Myanmar.
Recently, the company informed that its Marketing Authorisation Application for the oral spray ZolpiMistTM submitted to the Australian Therapeutic Goods Administration in early 2019, has been accepted for review.
SUDA has been negotiating with different pharma companies for the ZolpiMistTM license in other countries of South America as well as in the Middle East, UAE, Italy, Germany, North Africa, Spain, Korea, Kuwait and France. As stated by SUDA’s CEO, Mr Stephen Carter, in the company’s recently announced quarterly updates, SUDA expects the beginning of the FY 2019-20 to be very exciting with the completion of several negotiations.
Stock Performance: SUD closed the trading session flat at AUD 0.004 on 6th August 2019 with ~3.56 billion outstanding shares.
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