The 2019 coronavirus infectious disease (COVID-19) is caused by infection with the new severe acute respiratory syndrome coronavirus (SARS-CoV-2). Currently, the treatment options for COVID-19 are limited. The purpose of the experiments presented here was to investigate the effectiveness of ketotifen, naproxen and indomethacin, alone or in combination, in reducing SARS-CoV-2 replication. In addition, the cytotoxicity of the drugs was evaluated. The findings showed that the combination of ketotifen with indomethacin (SJP-002C) or naproxen both reduce viral yield. Compared to ketotifen alone (60% inhibition at EC₅₀), an increase in percentage inhibition of SARS-CoV-2 to 79%, 83% and 93% was found when co-administered with 25, 50 and 100 μM indomethacin, respectively. Compared to ketotifen alone, an increase in percentage inhibition of SARS-CoV-2 to 68%, 68% and 92% was found when co-administered with 25, 50 and 100 μM naproxen, respectively. For both drug combinations the observations suggest an additive or synergistic effect, compared to administering the drugs alone. No cytotoxic effects were observed for the administered dosages of ketotifen, naproxen, and indomethacin. Further research is warranted to investigate the efficacy of the combination of ketotifen with indomethacin (SJP-002C) or naproxen in the treatment of SARS-CoV-2 infection in humans.

Background. Despite a clear market need and many hangover products available, currently there is no hangover treatment that is supported by substantial scientific evidence demonstrating its efficacy and safety. A pilot study was conducted to investigate the effects of a potential new hangover treatment, SJP-001, and its constituents (220 mg naproxen and 60 mg fexofenadine) on hangover severity. Methods. N = 13 healthy social drinkers (36.3 ± 8.9 years old) participated in a double-blind, factorial design, cross-over study. On each test day, they consumed their own choice of alcohol up to a self-reported level sufficient to elicit a next-day hangover. Treatments were administered prior to onset of drinking. Next morning, hangover severity was assessed with the Acute Hangover Scale (AHS). Subjects were included in the efficacy analysis only if they reported a hangover after placebo. Results. N = 5 subjects (60% male, 35.2 ± 9.0 years old) were included in the analysis. They consumed a mean (SD) of 4.6 ± 1.1 units of alcohol and had an average peak breath alcohol concentration (BrAC) of 0.065% across conditions. Compared to placebo, SJP-001 significantly improved the AHS overall hangover severity score (0.8 ± 0.3 versus 1.5 ± 0.9, p = 0.042). Compared to placebo, SJP-001 also reduced scores on the individual item ‘hangover’, although the observed improvement (−1.6) did not reach statistical significance (p = 0.102). The differences from placebo after naproxen alone and fexofenadine alone were not statistically significant. SJP-001 also improved scores for the individual hangover symptoms tired, thirsty, headache, dizziness, nausea, and loss of appetite, but these effects did not reach statistical significance. Discussion. Compared to placebo, SJP-001 significantly reduced overall hangover severity. The effects of SJP-001 should be further examined in a double-blind, placebo-controlled trial with a larger sample size and controlled administration of sufficient amounts of alcohol to provoke a more substantial alcohol hangover.

A considerable number of travelers receive multiple travel vaccinations before going on holiday. Here, we present a case report of a 56-year-old male traveler. On day 1, he received vaccinations against influenza, Tdab (tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis), MMR (measles, mumps, and rubella), yellow fever, and cholera. On days 1,3, 5, and 7, he self-administered an oral vaccine against typhoid. Treatment comprised the combination of 220 mg naproxen and 180 mg fexofenadine (SJP-003), to be taken 4h before and 6h after the vaccinations on day 1, and every 12 h thereafter until the end of day 7. Side effects were noted daily, and their severity was scored on a scale ranging from 0 (absent) to 10 (severe). These reports revealed that, except from a slight bruising at the injection site, no side effects were experienced from day 1 to day 4. After the second dose on day 3, treatment was discontinued. Two hours after taking the typhoid vaccine on Day 5, various flu-like symptoms were reported of moderate to high severity, including fever, muscle aches (both with severity score of 8), headache (severity score 7), and nausea (severity score 6). Therefore, at 2 h after typhoid vaccination on day 5, naproxen and fexofenadine were self-administered. At 4 h thereafter, all symptoms were resolved. Treatment was continued at the 12 h schedule. On day 6 and 7, no side effects were reported. Taken together, this case study suggests that the combination of naproxen and fexofenadine was effective in preventing or reducing vaccination side effects. Therefore, more research is warranted to further evaluate the efficacy of SJP-003.

SJP-005 (a combination of ketotifen and ibuprofen) is being developed as a potential treatment for pain and for opioid use disorder. It is therefore important to investigate the potential antinociceptive properties of SJP-005. Two studies were conducted to evaluate the potential effects of SJP-005 in rats. Study 1 applied the von Frey test to examine the antinociceptive effect of morphine with and without SJP-005 in adjuvant-induced hypersensitivity to tactile stimulation. In a double-blind, between-groups design, groups of rats (n = 10 each) received morphine at 3, 10, or 30 mg/kg bodyweight (bw) (subcutaneous injection) with or without SJP-005 (oral). Mechanic allodynia and paw volume were assessed before and after treatment. Study 2 utilized the hot plate test. Using a crossover design, groups of rats (n = 10 each) received either morphine at 3, 10, or 30 mg/kg bw (subcutaneous injection) preceded by oral administration of placebo (Week 1) or SJP-005 (Week 2). In Study 1, in the von Frey up-and-down test, Δ paw withdrawal responses in Group 1 (3 mg/kg bw morphine) were significantly lower compared to those in Group 4 (3 mg/kg bw morphine plus SJP-005), whereas the differences in Δ paw withdrawal between Group 2 and Group 5 (10 mg/kg bw morphine with and without SJP-005) and between Group 3 and Group 6 (10 mg/kg bw morphine with and without SJP-005) did not reach statistical difference. Trendline analysis of the dose–response relationship for the morphine + placebo groups and morphine + SJP-005 groups revealed no significant differences in the intercepts and slopes. In Study 2, no significant differences were observed on hot plate performance between morphine and morphine in combination with SJP-005. In conclusion, the findings in the von Frey up-and-down test (Study 1) suggest that animals can withstand higher levels of painful stimuli when SJP-005 is co-administered. This may also suggest a possible opioid sparing effect. However, in the hot plate test (Study 2), animals did not respond more adaptively to stronger painful stimuli after co-administering SJP-005. These observations warrant further investigation of the antinociceptive properties of SJP-005.

The influenza virus is associated with sickness, and in particular among vulnerable populations such as elderly and those with underlying disease with hospitalization and increased mortality rates. Vaccination is an effective way to prevent infection with influenza. However, undesirable side effects of the vaccination are commonly experienced, and comprise one of the primary reasons for a substantial group of individuals to refrain from vaccination. An effective treatment against vaccination side effects could increase the overall willingness to vaccinate against influenza. Here, four cases are presented that self-administered SJP-003 (a combination of 220 mg naproxen sodium, directly followed by a single oral dose of 60 mg fexofenadine HCL), 2 h before and 10 h after influenza vaccination. No flu-like symptoms and pain at the injection site were reported. These observations warrant further investigation of SJP-003 in double-blind, placebo-controlled clinical trials.

Key Clinical Message: There is no effective treatment that reduces both the severity and duration of a common cold episode. SJP − 002 (naproxen and fexofenadine) reduced symptom severity by two‐third, and the duration of the common cold episode approximately by half. The common cold is one of the most frequently experienced immune‐related complaints. At present, available treatments have limited efficacy in inhibiting symptoms associated with upper respiratory tract infection, nor do they significantly shorten the duration of common cold episodes. Four case reports are presented of individuals with a common cold. Three of them self‐administered the combination of naproxen and fexofenadine (SJP − 002). Results of one individual were compared to her spouse, who did not take SJP − 002 to treat common cold, while two other individuals took SJP − 002 and compared symptom severity with another common cold episode they experienced previously without taking SJP − 002. SJP − 002 reduced the severity of symptoms associated with upper respiratory tract infection by two‐third and reduced the duration of the common cold episode approximately by half. In conclusion, SJP − 002 reduced the severity and duration of common cold episodes. These findings warrant further investigation of SJP − 002 in double‐blind, placebo‐controlled clinical trials.